Biosimilar Development News

  1. BioDlink's Bevacizumab Approved For Market Launch In Indonesia, Marking Fourth Consecutive Emerging Market Authorization 8/21/2025

    BioDlink announced that its Bevacizumab Injection has obtained marketing authorization from Indonesia's National Agency of Drug and Food Control (BPOM). This marks BioDlink's fourth international approval within two months – following Nigeria, Pakistan, and Colombia – signaling accelerated BioDlink's global expansion into a sustained commercialization phase.

  2. Accord BioPharma Announces Commercial Launch Of IMULDOSA® (ustekinumab-srlf) Prefilled Syringes At Lowest WAC Price Among Branded Biosimilars To STELARA® (ustekinumab) 8/18/2025

    Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced today the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab). IMULDOSA prefilled syringes, which would represent the majority of the presentations in the ustekinumab market, are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars at a 92% discount from STELARA. FDA-approved for the same indications as the reference product, IMULDOSA represents Accord BioPharma's third in-market biosimilar and furthers the company's mission to expand patient access to potentially life-changing biologic therapies.¹ Accord BioPharma is committed to providing patients with greater access to ustekinumab through this significant cost reduction.

  3. MedImpact Offers Low Cost, Unbranded Ustekinumab-aekn Biosimilar To Any Specialty Pharmacy In The US 8/18/2025

    MedImpact Holdings Inc. today announced that it will have access to an unbranded biosimilar ustekinumab-aekn at a significantly lower cost than the reference Stelara (ustekinumab).

  4. BioDlink Accelerates Global Expansion With Bevacizumab Launch In Colombia And Pakistan 8/13/2025

    BioDlink announced that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia's National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan's Drug Regulatory Authority of Pakistan (DRAP).

  5. Lupin Announces Licensing Deal For Ranibizumab Biosimilar 8/12/2025

    Global Pharma major Lupin Limited (Lupin) today announced that it has partnered with Sandoz Group AG (Sandoz), Switzerland, to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.

  6. Intas Pharmaceuticals And Accord Biopharma Become One Of The Largest Global Suppliers Of Pegfilgrastim With Acquisition Of UDENYCA® 8/6/2025

    Intas Pharmaceuticals in collaboration with its global subsidiaries operating under the Accord brand, has solidified its position as one of the world's leading suppliers of pegfilgrastim following the successful acquisition of UDENYCA® (pegfilgrastim-cbqv) from Coherus BioSciences, Inc.

  7. FDA Approves Expanded Indication For AVTOZMA® (tocilizumab-anoh) intravenous (IV) Formulation In Cytokine Release Syndrome (CRS) 8/6/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older. 

  8. Polpharma Biologics And Fresenius Kabi Sign Licensing Agreement For Proposed Vedolizumab Biosimilar PB016 8/5/2025

    Polpharma Biologics S.A. (“Polpharma Biologics”) announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn’s disease.

  9. Kashiv BioSciences And MS Pharma Enter Into MENA License And Supply Agreement For ADL-018, Biosimilar Candidate To XOLAIR (bOmalizumab) 8/5/2025

    Kashiv BioSciences, LLC and MS Pharma today announced that the companies have entered into a license and supply agreement for ADL-018, Kashiv BioSciences’ biosimilar candidate to XOLAIR (bOmalizumab) in the Middle East and North Africa (MENA) region. IQVIA reported global sales of ~$4.5B and ~$60M in MENA in 2024.

  10. CivicaScript® To Distribute Low-Cost Biosimilar To Treat Chronic Inflammatory Conditions 8/5/2025

    CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines to U.S. patients, today announced that it will distribute the biosimilar ustekinumab-aauz, used for treatment of chronic inflammatory conditions in certain patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.