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Thermo Fisher Scientific announced that it has expanded its St Louis biologics manufacturing facility, adding up to four Thermo Scientific™ bioreactors, each of which can process up to 5,000 liters.

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® ...

Novartis announced it successfully completed the spin-off of Sandoz, its former generics and biosimilars business on 4 October 2023.  Sandoz also made its own announcement about the spin-off, noting it completed its first trading day on the Swiss Exchange on 4 October with ...

A PLOS One study found that there was no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. The study examined unique studies and switch treatment periods for each reference...

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...