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The Biden Administration proposes to amend s352 of the Public Health Service Act so that all approved biosimilars are deemed to be interchangeable with their respective reference drug.
On 11 March 2024, the Biden Administration released its 2025 Budget Proposal in whi...

Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab).  Celltrion’s application seeks approval for all Xolair® indications, as well a...

On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases includ...

On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.  The product is currently approved in the US ...

On 11 March 2024, MSD announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M with the aim of augmenting and diversifying their oncology pipeline.  Harpoon’s lead candidate is MK-6070 and its safety, tolerability and pharmacokinetics profile ...

On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based chemothe...

On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024.  The approval was based on Phase 3 randomized trials in patients aged 8-17.  The results, published in t...