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Coherus Announces Proposed Neulasta Biosimilar Met Primary Endpoints in Immunogenicity Study

Coherus announced yesterday “a key achievement in support of [its] planned Biologics License Application (BLA) filing” for a proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim): its proposed biosimilar, CHS-1701, has “met both primary endpoints in a double-blind, randomized, two-period, parallel-arm clinical study in 303 healthy subjects.” If accepted for FDA review,…

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UK’s National Institute for Health and Care Excellence Announces Preference for Biosimilars

The National Institute for Health and Care Excellence (“NICE”) released guidance today establishing a preference for lower-cost biosimilars for the treatment of rheumatoid arthritis. NICE is an agency that provides cost-effectiveness and other guidance to the National Health Service (“NHS”) and other British public health services.  The guidance document released today provides…

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Busy Month Ahead for BPCIA Interpretation Questions

February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…

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FDA Plans to Release Biosimilarity Guidances in 2016

Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…

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Sorrento Announces Successful Phase III Trials for Biosimilars of Erbitux (cetuximab) and Remicade (infliximab)

On January 11th, Sorrento Therapeutics announced that its partner, MabTech Ltd., had successfully completed Phase III clinical trials in China for two drugs: STI-001, a biosimilar of Eli Lilly’s Erbitux (cetuximab), and STI-002, a biosimilar of Janssen Biotech’s Remicade (infliximab). Both STI-001 and STI-002 met their primary endpoints in confirmatory,…

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Biogen Announces Approval for Biosimilar of Amgen’s Enbrel

Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….

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