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FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biological product development and regulatory science”.

Shanghai Junshi Biosciences announced that China’s NMPA has approved its biosimilar adalimumab product (50mg/ml) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.  The product was jointly developed by Shanghai Junshi Biosciences and Jiangsu T-...

Celltrion launched Yuflyma® (high concentration citrate-free biosimilar adalimumab) in Korea.

AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments.  This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portf...

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar p...

In this Boutique Lawyer Show podcast, Pearce IP’s CEO and Executive Naomi Pearce speaks candidly with Lawyers Weekly’s Jerome Doraisamy

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently co...

Biocon announced that its subsidiary Biocon Biologics will acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash to create a vertically integrated biosimilars leader.  The transaction is expected to close in the second half of 2022, subject to condition...