pfizer adalimumab biosimilar

4 Zhao S, Chadwick L, Mysler E, Moots RJ. Switching from reference to biosimilar adalimumab is safe for patients who are stable and in clinical remission. For more than 150 years, we have worked to make a difference for all who rely on us. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. Similar to generic drugs, biosimilar Humira will save patients money on this medication. (adalimumab-aqvh) December 2021: Humira . If an infection develops, monitor carefully and initiate appropriate therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Risks and uncertainties include, among other things, uncertainties regarding the launch timing and commercial success of ABRILADA in the United States; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for ABRILADA may be filed in any other jurisdictions; whether and when any such other applications for ABRILADA that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy and, if approved, whether ABRILADA will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRILADA; uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to the innovator product; and competitive developments. The approval of Humira biosimilar is the fourth U.S. nod to a biosimilar product for Pfizer in 2019. Arthritis Res Ther. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. ADL-PF was generally well tolerated, with a comparable safety profile across groups. 4 World Historic Review for Adalimumab, Infliximab And Etanercept Biosimilars by Geographic Region 4.1 World Historic Market Size by Geographic Region (2017-2022) 4.1.1 Global Annual Sales by . Incidence of treatment-emergent adverse events (AEs) during TP3 and follow-up was 42.6% (biosimilar), 37.0% (week 26 switch), and 50.8% (week 52 switch); 3 (0.6%) patients (all week 52 switch) reported treatment-related serious AEs. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. We routinely post information that may be important to investors on our website at www.pfizer.com. NY: Pfizer Inc: 2019. +1 (978) 273-3946 It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Patients on ABRILADA should not receive live vaccines. To support clinical development of PF-06410293, an adalimumab biosimilar, nonclinical studies evaluated the structural, functional, toxicologic, and toxicokinetic similarity to originator adalimumab sourced from the United States (adalimumab-US) and European Union (adalimumab-EU). Accessed November 2019. Consider stopping ABRILADA if significant hematologic abnormalities occur. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. AVT02 acts as immunosuppressants and tumour necrosis factor alpha inhibitors. Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab; exercise caution and monitor carefully. Accessed February 2022. Phase 3 Data on Samsung Bioepis Eculizumab Biosimilar Confirms Equivalence to Soliris, Denosumab Biosimilar Competitors Gathering Data for February 2025 Launch. Although Pfizer would not confirm its plans for the US filing, phase 3 trial results for PF-06410293 have been published, establishing the biosimilars equivalency to Humirain terms of efficacy, safety, and immunogenicity. Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. By potentially reducing costs while retaining safety, efficacy, and quality standards, biosimilars may be able to unlock resources that can be reinvested in things like improving patient care. Pfizer's Biosimilar Earnings Pfizer reported first quarter 2021 revenues of $14.6 billion, up 45% from the comparable year-ago quarter, and stated that increased biosimilar revenues partly helped fuel this growth, although the bulk of the revenue increase stemmed from $3.5 billion in sales of Pfizer's COVID-19 vaccine, BNT162b2. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of ABRILADA and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.3. . All rights reserved. Third is the issue that has been looming for a couple of years nowthe potential for Boehringer Ingelheim to score interchangeability status for Cyltezo , which would be unique among adalimumab biosimilars. This site uses Akismet to reduce spam. [4] Health Canada Biosimilar biologic drugs in Canada: Fact Sheet. Abrilada: Pfizer . If this guess is accurate, that leaves $9 billion for seven or so biosimilar makers. 2022 MJH Life Sciences and Center for Biosimilars. Our current plans are to launch in 2023. The FDA originally approved Abrilada in November 2019 . Pfizer believes that the market for. These cases have had a very aggressive disease course and have been fatal. ABP 710 was the subject of a phase 3 trial in patients with moderate-to-severe rheumatoid arthritis; researchers concluded that the drug was equivalent to Remicade in terms of efficacy, safety and immunogenicity. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with ABRILADA. Pfizer (NYSE: PFE) announced on Friday that the U.S. Food and Drug Administration (FDA) accepted its supplemental marketing application for Abrilada (adalimumab-afzb) that sought regulatory. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Data have been supplied for the projected period and the base year 2021 for market estimations (2022-2030). Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Discontinue treatment if symptoms of a lupus-like syndrome develop. November 30, 2018 Big Molecule Watch AbbVie, Adalimumab, Biosimilars News, Pfizer Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer's proposed biosimilar adalimumab. 5-8,49 The use of these distinguishable . Pfizer did not elaborate on why the decision was made to submit applications for both the skinny label and the full set of indications. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general. pfizer inc. (nyse: pfe) today announced the united states (u.s.) food and drug administration (fda) has approved abrilada (adalimumab-afzb), as a biosimilar to humira (adalimumab), 1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult crohn's A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Exercise caution when considering ABRILADA for patients with these disorders; discontinuation of ABRILADA should be considered if any of these disorders develop. Abrilada is an FDA-approved biosimilar version of adalimumab. 1 Humira is a registered trademark of AbbVie. Pfizer has decided to focus on gaining approval for the full slate of indications and withdrew the other application. Discontinue treatment if symptoms of a lupus-like syndrome develop. Our diversified healthcare portfolio includes some of the worlds best known and most prescribed medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Adalimumab, Infliximab and Etanercept Biosimilars Global Market Research Report 2021 Featuring Zydus Cadila, Sandoz, Samsung Bioepis, AbbVie, Amgen, Boehringer Ingelheim, Pfizer, Celltrion, and . Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. TNF blockers, including adalimumab, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barr syndrome. Risks and uncertainties include, among other things, uncertainties regarding the launch timing and commercial success of ABRILADA in. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. The majority of reported TNF blocker cases have occurred in patients with Crohns disease or ulcerative colitis and the majority were in adolescent and young adult males. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo's . ACR20, 50, and 70 rates were also similar through week 26 for both groups. Interchangeable status has the potential to boost uptake of the product, which is scheduled to launch against 5 other adalimumab biosimilars in 2023. Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn's disease: an observational study Rev Esp Enferm Dig. Medically significant cytopenia has been infrequently reported with adalimumab. In the biosimilar arm, 68.7% of patients achieved ACR20, as did 72.7% of patients in the reference arm; the treatment difference was 3.98%, which was contained within the prespecified equivalence margin of 14%. In the US, the biosimilar is still known as PF-06410293 . Accessed November 2019. Final gross price and currency may vary according to local VAT and billing address. Pfizer signed a licensing deal with Abbvie on November 30 to market this adalimumab biosimilar in the US. Adis is an information provider. Research and development are at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies that matter most. Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. Todays filing would put this biosimilar on a path to a late Q3 or early Q4 2019 decision by the FDA. AVT02 is a monoclonal antibody and an approved biosimilar to Humira (adalimumab) in the EU, the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra) and Canada (Simlandi). As a . Steve.Danehy@pfizer.com, Investor Contact: An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. [3] Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. Ryan Crowe Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12780. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We do not sell or distribute actual drugs. Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. We routinely post information that may be important to investors on our website at www.pfizer.com. Semglee's reference product is Lantus (insulin glargine), a more expensive insulin product. Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. This release contains forward-looking information about ABRILADA (adalimumab-afzb) including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients., The Health Canada approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference biologic drug Humira. Can Biosimilar Development Costs Be Genericized? Eye on Pharma: Natalizumab Injunction, Oral Ustekinumab Development, and New Study for Secukinumab Biosimilar, Dr Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar Market, AMCP Nexus Abstracts Investigate Adoption, Budget Impact of Biosimilars, WHEN CHOICE ARRIVES: Competition & Consequences. It is being developed for the treatment plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, crohn's disease, ulcerative colitis. Published Nov 2, 2022. Our current plans are to launch in 2023. See how we support the people in the communities where we work and live through our community investment partnerships. Price : $50 *. Pfizer has announced plans to file for an interchangeable biosimilar version of adalimumab in the US, ahead of its expected launch of its already-approved Humira biosimilar Abrilada (adalimumab-afzb) in July 2023. New York. Dec 3, 2018 9:55AM EST AbbVie, Inc. ABBV signed a non-exclusive licensing deal with Pfizer PFE regarding the latter's proposed biosimilar version of its blockbuster rheumatoid arthritis drug,. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Who Are the Key Aflibercept Biosimilar Players to Watch? Available at https://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract. Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients., The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference product. Use of TNF blockers, including adalimumab, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients., The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference product. Health Canada uses the same rigorous standards for quality, efficacy and safety when authorizing a biosimilar as any other biologic drug.4 Since 2009, Health Canada has approved 45 biosimilars for use by Canadian patients to treat cancer, diabetes, arthritis and inflammatory bowel disease.5. For more than 150 years, we have worked to make a difference for all who rely on us. AVT02 is a monoclonal antibody (mAb) and a proposed biosimilar to Humira (adalimumab). Ryan.Crowe@pfizer.com. This post was updated and corrected on December 18, 2018. To learn more about Pfizer Canada, visitpfizer.caor you can follow us on LinkedIn, Facebook, Twitter or YouTube. Accessed November 2019. All rights reserved. According to Pfizers Director of Global Media Relations, Thomas Biegi, the company had submitted two applications for this biosimilar, one for a limited set of indications, and the other for the full array of autoimmune indications of the reference product Humira. Exercise caution in patients who are carriers of HBV and monitor them during and after ABRILADA treatment. Pfizer Inc.: Breakthroughs that change patients lives. Learn more. Adalimumab targets and blocks TNF, which is believed to help reduce inflammation.4, IMPORTANT SAFETY INFORMATION for ABRILADA (adalimumab-afzb). Steve.Danehy@pfizer.com, Investor Contact: These cases have had a very aggressive disease course and have been fatal. Treatment with adalimumab may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12780. +1 (212) 733-8160 Available athttps://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract Accessed February 2022. Latest Information Update: 23 Mar 2022. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. With more than 10 years of global in-market experience and eight approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. You'll now be able to see real-time price and activity for your symbols on the My Quotes of Nasdaq.com. No doubt, Pfizer is surveying the heavy competition for adalimumab in Europe today. In addition, to learn more, please visit us on. Copyright Pfizer Canada 2021 Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. A third biosimilar version of adalimumab, AVT02, developed by Alvotech and with US licensing by Teva, has the potential to launch in 2023, although it has yet to obtain FDA approval, too. Immunogenicity does not seem to be different after switching from reference to biosimilar adalimumab. We routinely post information that may be important to investors on our website at, . Pfizer adalimumab biosimilar update As per the agreement Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. In other biosimilar newsAmgen has announced the filing of a new biosimilar version of infliximab. The biosimilar was studied in a 78-week, double-blind, multicenter, randomized study comparing the proposed biosimilar with EU-licensed Humira in 597 biologic-nave patients with rheumatoid arthritis, and 26-week results of the study have been published.1. Accessed November 2019. Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. Do not start ABRILADA during an active infection, including localized infections. Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. new york -- (business wire)-- pfizer inc. (nyse: pfe) today announced the united states (u.s.) food and drug administration (fda) has approved abrilada (adalimumab-afzb), as a biosimilar to. 1 ADL has been shown to reduce . Pfizer Inc.: Breakthroughs that change patients lives. We will provide further updates as the date approaches. If an infection develops, monitor carefully and initiate appropriate therapy. The potential brand name of the biosimilar if approved with all of the reference products indications was not disclosed. Biosimilars, Biologics, FDA Policy and Approvals, Clinical Trials, and Specialty Pharmacy. Discontinue ABRILADA and begin antiviral therapy in patients who develop HBV reactivation. Create your Watchlist to save your favorite quotes on Nasdaq.com. Use of TNF blockers, including adalimumab, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Available at https://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract. When the symbol you want to add appears, add it to My Quotes by selecting it and pressing Enter/Return. 3 Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. Find out about our diversified health care portfolio which includes some of the worlds best-known prescription medicines and vaccines. [1] Humira is a registered trademark of AbbVie. Outsmart the market with Smart Portfolio analytical tools powered by TipRanks. Pfizer, meanwhile, said global biosimilar sales surpassed $900 million in 2019. It will be the sixth biosimilar to enter the market in 2023, based on this deal. The FDA has approved Pfizers adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira. Can Biosimilars Fund New Specialty Pipeline Development? Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Introduction. Available at www.pfizer.ca. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Under the terms of the agreements, AbbVie grants Pfizer a non-exclusive patent license for the use and sale of Pfizer's proposed adalimumab biosimilar for many countries around the world. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.2 For full details of indications please see the approved label. Ryan.Crowe@pfizer.com, At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. You are now leaving the Pfizer.ca website and entering Pfizer.com where the information presented, including product information, may have different labeling than in Canada, and the Canadian Privacy Policy does not apply. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Pfizer's pipeline consists of eight distinct biosimilar molecules in mid- to late-stage development, apart from several others in earlier stages. Under the skinny label, the product would have been marketed as Fyzoclad in Europe. 3. Pfizer has nearly a decade of experience bringing biosimilar biologics to patients around the world. Pfizer said financial details were confidential and disclosed no further information on the settlement mirroring the approach of other companies which have reached deals with AbbVie. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Therefore, Pfizer must believe that a sixth biosimilar entrant to the US market at that time may still yield relevant revenues and marketshare. This would make it the sixth adalimumab biosimilar to launch, just before Momenta's M923 agent and just after Sandoz's biosimilar Hyrimoz . Concomitant administration of ABRILADA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. Media Contact: Details Pfizer 02 December 2019 Pfizer Inc. (NYSE: PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab),(1) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative . Pfizer's trastuzumab biosimilar (PF 05280014) referencing Herceptin is in registration phase; and will continue to develop the following biosimilar products: 1) rituximab biosimilar (PF 05280586) referencing Rituxan; 2) adalimumab biosimilar (PF 06410293) referencing Humira; 3) bevacizumab biosimilar (PF 06439535) referencing Avastin; and 4 . The drug, PF-06410293, is a monoclonal antibody that is a potential biosimilar of Humira (adalimumab). Arthritis Res Ther. Enter your email address to subscribe to this blog and receive notifications of new posts by email. "Today's announcement builds on Pfizer's robust biosimilar pipeline which has now delivered positive top-line data results for three of our proposed biosimilars," said Sumant Ramachandra, MD, PhD, MBA, Head of Research and Development, Pfizer Essential Health. Concomitant administration of ABRILADA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. There is a known association between intermediate uveitis and central demyelinating disorders. View source version on businesswire.com: https://www.businesswire.com/news/home/20191118005208/en/, Media Contact: It's a long-acting insulin used to help control blood sugar levels in diabetes. Medically significant cytopenia has been infrequently reported with adalimumab. Pfizer just launched Rituxan and Avastin biosimilars and is preparing to release a version of Herceptin in February. The majority of reported TNF blocker cases have occurred in patients with Crohns disease or ulcerative colitis and the majority were in adolescent and young adult males. Biosimilar Drug Profile: Abrilada is an FDA-approved biosimilar version of adalimumab (reference product, Humira , AbbVie).

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pfizer adalimumab biosimilar