Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization of two late-stage oncology medicines, IBI363 and IBI343. According to Takeda, IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein, is being evaluated in…
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government. With the increasing market share of more expensive biologic prescriptions, those…
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a…
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab Litigation”). The FDA subsequently, in March 2024, approved Sandoz’s denosumab biosimilars, WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz), as…
In honor of Women’s History Month, Big Molecule Watch recognizes Brigitte “Ita” Askonas, widely regarded as the mother of modern immunology. Born one hundred years ago, Dr. Askonas contributed to our understanding of the origin and synthesis of antibodies and the body’s immune response. In 1952, she joined the National…
On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate. BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6 receptor monoclonal antibody indicated for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic…
Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States: ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product. ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent…
On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed biosimilar to Roche’s AVASTIN®, in the United States, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and…
The ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics will be held on June 28 – 29, to contemplate the details of the rapidly changing landscape for biosimilars and innovator biologics. Goodwin is a proud sponsor of the conference and, Goodwin partner and Big Molecule Watch editor, Huiya Wu is a…