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Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio
Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
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Immutep and Dr. Reddy’s Laboratories have entered into a strategic collaboration and exclusive licensing agreement to develop and commercialize Eftilagimod Alfa (efti) across all countries outside North America, Europe, Japan, and Greater China
As per the deal, Immutep will receive a $20M (~AUD 30.2M) upfront payment from Dr. Reddy’s, plus potential milestone payments of up…
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Samsung Bioepis has signed a confidential settlement and license agreement with Johnson & Johnson for the commercialization of Pyzchiva, its Stelara (ustekinumab) biosimilar in Europe
Ustekinumab is an IgG1κ monoclonal antibody targeting IL-12 and IL-23. PYZCHIVA, developed by Samsung Bioepis, received European Commission approval as a Stelara biosimilar in April 2024
PYZCHIVA was introduced in the EU by Sandoz in July…
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Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM
As per the deal, Klinge will receive…
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Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships
The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology
As…
The US FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for treating primary immunodeficiency (PI) pts (age≥2); commercialization will be anticipated in 2026 and in the EU in 2027, where it’s approved as DEQSIGA by the EMA
GAMMAGARD LIQUID ERC is a 10% ready-to-use IG therapy with ≤2 µg/mL IgA, for IV or…
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Philochem and RayzeBio (BMS) entered into a development and commercialization agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize its radiopharmaceutical agent OncoACP3 for prostate cancer
Under the agreement, Philochem will receive $350M up front and is eligible for up to $1B in development, regulatory, and commercial milestones, plus…
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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 patients
Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…
Shots:
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 patients
Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…
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The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil
Qfitlia published clinical data in the NEJM in 2017, showing…

