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On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.

Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or lo...

On 28 April 2026, Celltrion announced the launch of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in Japan.  Avtozma® is the first tocilizumab biosimilar to be launched in Japan, having also been the first to receive approval in September 2025.

Avtoz...

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syr...

On 27 April 2026, Jazz Pharmaceuticals announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) in combination with BeOne’s (formerly BeiGene’s) Tevimbra® (tislelizumab) and chemotherapy for the ...

On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) ...

On 27 April 2026, Sun Pharmaceutical Industries Limited and Organon & Co announced that they have entered into a definitive agreement for the acquisition by Sun Pharma of all outstanding shares of Organon in an all-cash transaction valued at US$11.75 billion.

The...

On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive opinions for one biosimilar and for extended indications of 9 already approved medicines.

Inta...

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027.  This includes:

biosimilars that are already on the market: Alymsys® (bevacizumab) (...

At its meeting on 22 April 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended approval of Enzene’s Phase 3 clinical trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of biosimilar ...