On March 20, 2023, Coya Therapeutics, Inc. (“Coya”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. COYA 302 is a dual biologic comprised of COYA 301 and…
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris. Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022. The CRL relates…
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to biosimilars, an American problem.”[1] The article, published in the Journal of Law and the Biosciences, examines whether patent…
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…
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…
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…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization. KAULIV is a biosimilar referencing…
Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada. AYBINTIO is a biosimilar product referencing AVASTIN (bevacizumab) and is approved for adults with certain aggressive forms of cancers, including metastatic…