As reported by HealthCareRadius in India, on February 23, 2023, Enzene Biosciences, a subsidiary of Alkem Laboratories, announced commencement of commercial supplies of its biosimilar adalimumab (ENZ-129) in India to treat ankylosing spondylitis (AS) and rheumatoid arthritis (RA). This is Enzene’s fourth biosimilar launch in the last eighteen months. In…
This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221). The patents are generally directed to processes for producing an antibody or an antibody fragment by transforming a host cell with a first and…
On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023. As we previously reported, the USPTO requested public input on areas for USPTO-FDA collaboration and engagement in response to President Biden’s Executive Order to “help ensure that the patent system, while incentivizing…
Goodwin’s Life Sciences team does extensive work with innovators in the rare disease space. In recognition of Rare Disease Day and participation in the National Organization for Rare Disorders’ (NORD) Rare Disease Day campaign to raise awareness, Goodwin’s Boston, DC, Silicon Valley and Santa Monica offices were lit in rare…
On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein. SOLIRIS® is approved for the treatment of paroxysmal…
Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to develop and commercialize a subcutaneous version of a Sandoz biosimilar product. Sandoz also has an option to license the Hybrozyme™…
The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the “application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and…
Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions challenging U.S. Patent No. 10,130,681: IPR2023-00442 (Samsung), IPR2023-00532 (Celltrion), and U.S. Patent No. 10,888,601: IPR2023-00566 (Samsung), IPR2023-00533 (Celltrion). As we previously reported, Mylan…
Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius Kabi’s first biosimilar approved by the FDA on September 6, 2022 and is now Fresenius Kabi’s first biosimilar to launch in the United States. …
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…