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Germany’s Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch.  Read more

Plaintiffs Sanofi and Regeneron filed a notice of voluntary dismissal, discontinuing without prejudice the proceedings they commenced in the District Court of Massachusetts in March 2017 in which they were seeking a declaration of non-infringement in relation to Amgen’s Dup...

Glenmark announces FDA approval for Phase I clinical trials of omalizumab.

FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.

Sandoz receives a Notice of Compliance for Erelzi® for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis.  (Sandoz did not seek registration for pso...

Samsung’s biosimilar etanercept, Brenzys, is listed on the PBS in Australia with “A” flagging enabling substitution at the pharmacy level

Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.

Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487.  The petitioners argue that the ‘487 patent is invalid on novelty grounds.  Earlier this month Sanofi and Regeneron filed a complaint in the District Court of...

EMA approves Amgen’s biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.