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An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin a...

Alvotech announced it has partnered with Kashiv Biosciences for an exclusive licensing agreement concerning AVT23 (ADL018), a proposed biosimilar to Novartis/Genentech’s Xolair®, extending across 27 EU countries, the UK, Australia, Canada, and New Zealand.  Alvotech will re...

The Nobel Assembly at Karolinska Institutet awarded the 2023 Nobel Prize in Physiology or Medicine jointly to Katalin Karikó and Drew Weissman for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVI...

Kashiv Biosciences announced that it has enrolled its first patient in a phase III clinical study of ADL018, its biosimilar to Novartis/Genentech’s Xolair® (omalizumab).  The objective of the study is to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability,...

FDA has approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

The Celltrion 80mg adalimumab auto-injector and pre-filled syringe were approve...

Boehringer Ingelheim announced that its unbranded interchangeable biosimilar to AbbVie’s Humira®, is now available at a low wholesale acquisition cost, at a 81% discount to Humira®.  It is also available under the brand name Cyltezo® priced at a 5% discount to Humira®.

Viatris announced it has received an offer for divestiture of most of its Over-the-Counter (OTC) business from Cooper Consumer Health, and has entered into agreements to divest its Women’s Healthcare business (oral and injectable contraceptives) to Insud Pharma, women...

Biogen announced that the FDA has approved Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® (tocilizumab) for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  ...

Outlook Therapeutics announced that it requested a Type A meeting with the FDA to discuss its Complete Response Letter (CRL) regarding its BLA for ONS-5010, the first ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®.  In the CRL dated 30 August 2023,...