In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22,…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22,…
On May 20, 2024, Teva Pharmaceuticals (“Teva”) and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the United States, for the treatment of adult…
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA….
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar….
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…
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation…
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen…
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). The product was approved as…
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation,…
Regeneron’s request for multi-district litigation As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish…