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Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
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Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC
Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…
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Prestige Biopharma has entered into an exclusive license & supply agreement with Biosidus to commercialize Tuznue, a biosimilar version of Herceptin (trastuzumab) across Latin American markets, incl. Argentina, Mexico, Bolivia, & Paraguay
As per the deal, Biosidus gains exclusive rights to market & distribute Tuznue in Argentina, Mexico, Bolivia & Paraguay, while Prestige Biopharma…
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Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets
As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities
Tuznue, biosimilar of Herceptin, with…
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The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer
The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile,…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of July, Polpharma Biologics reported EMA's acceptance of MAA…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of May, JSR Life Sciences launches Similis Bio business…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of March, Junshi & Mabwell Bioscience’s Junmaikang (biosimilar, adalimumab)…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of February, Biocon acquired Viatris’ biosimilars assets for ~$3.335B,…

