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PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea® (aflibercept),  invalidating all claims the subject of the Mylan challenge, for anticipation.  Mylan’s IPRs were heard by PTAB in August 2022.  Regeneron filed...

Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading biosimilar market share in the US within the first four weeks of launch, with 2023 net sales expected to exceed $100 million.  Coherus’ net revenue for the...

NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer.  NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (Decem...

Significant biosimilar activities this week include:

04 Nov 22 | New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects in AD patients

A new study involving 295 patients with AD published in JAMA repo...

The MHRA has updated its guidance on the licensing of biosimilars to allow interchangeability between biosimilars to the same reference product at the prescriber level.  The MHRA’s position on pharmacy substitution (not allowed) remains unchanged.  This follows a similar mo...

Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on 10-14 November 2022, including data for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

On Friday, the US Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it m...

Accord Healthcare was the clear winner at the Global Generics and Biosimilars Awards which were presented on 2 November in Frankfurt, achieving “Biosimilar Initiative of the Year”, “Company of the Year”, “Value Added Medicine Initiative of the Year”, and “Regulatory Achieve...

Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab (Cosentyx®) in patients with moderate to severe plaque psoriasis.