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Alvotech and Teva Announce Acceptance of BLA for AVT04, a Proposed Biosimilar to STELARA (ustekinumab)

On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies anticipate that the FDA’s review will be completed in the second half of 2023. In August 2020,…

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Alvotech Initiates Study of Biosimilar of J&J's Rheumatoid Arthritis Drug SIMPONI

Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab).  SIMPONI is used to treat certain types of rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and ulcerative colitis (UC). The study will assess…

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Coherus Agrees to Acquire a Biosimilar EYLEA Candidate from Klinge Biopharma

On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge Biopharma”) in the US. The parties expect to complete the transaction in Q1 2023.  Coherus plans to file an abbreviated…

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Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

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Alvotech Broadens Access to HUMIRA (adalimumab) Biosimilars

Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…

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AbbVie’s Q322 Earnings Call Highlights Oncoming Adalimumab Biosimilar Competition

Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023.  Some highlights below: According to Rick Gonzalez, AbbVie Chairman and CEO, “[t]he current market dynamics do not change our long-term guidance for aesthetics and we…

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EMA Adopts Positive Opinion for STADA and Xbrane’s Ranibuzumab Biosimilar Candidate XIMLUCI®

On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for XIMLUCI®.  XIMLUCI® is a biosimilar candidate referencing LUCENTIS® (ranibizumab), which is an anti-VEGF (vascular endothelial…

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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Denosumab Biosimilar

Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.  According to Alvotech, the results from this trial will be…

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FDA Workshop on Sept. 19, 2022: Increasing the Efficiency of Biosimilar Development Programs

The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.”  The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.”  The workshop will include detailed discussion on the statistical methods…

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