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Samsung revealed in a South Korean regulatory filing that it has entered into a KRW$241 billion (~USD$183M) contract with Pfizer. The ‘Biologics CMO Contract’ is effective between 28 February 2023 and 31 December 2029 and relates to the manufacture of unnamed biologics by S...

The FDA provided an update on its collaboration with the Federal Trade Commission (FTC) which it announced in February 2020.  The FDA and FTC have been working together on issues including exchanging information about how to combat anti-competitive activities and those that...

A Turgut İlaçları study published in the Turkish Journal of Pharmaceutical Sciences indicated that Turgut’s TUR01, biosimilar to Amgen’s Humira® (adalimumab), was stable when stored under long-term storage conditions at for at least 18 months and for 24 months.  In 2020, Tu...

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatit...

Alvotech announced its full financial results for 2022, highlighting its annual revenue increased by 114% to USD$85M, primarily driven by the commercialisation of AVT02 (adalimumab), biosimilar to AbbVie’s Humira® in 17 countries.  As of December 31, 2022, the company had c...

PTAB denied institution of Mylan’s IPR challenge to US10,857,205 (relating to Regeneron’s Eylea® aflibercept), after Regeneron filed a disclaimer with the USPTO, disclaiming all claims of the patent.   

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On 1 March 2023, the PBS published its Summary of Changes, which included listing Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.4ml pre-filled pen and syringes.  This comes after Yuflyma® was recommended for PBS-listing by the Austr...

A new study published in Gastroenterology Research and Practice has found that British Columbia’s 2019 ‘Biosimilars Initiative’ was not associated with harmful impacts on medications and health services use.  The Initiative required IBD patients to switch from Johnson &...

Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s Humira®) in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.  Enzene believes that this is the first commercial launch using continuous manufactu...

Celltrion filed an application for inter-partes review (IPR) against a fourth Regeneron US patent 10,406,226 relating to a method of making a VEGF antagonist fusion protein, including the fusion protein aflibercept supplied by Regeneron as Eylea®.    

Celltrion previ...