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Apr 25, 2024
On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen's Wezenla™ (ustekinumab), biosimilar to Janssen's Stelara®. Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injection, as...
Apr 25, 2024
On 25 April 2024, Evernorth, a provider of health services and member of the Cigna Group, announced that it will offer biosimilar adalimumab to US patients with no patient out-of-pocket costs from June 2024, resulting in savings to the patient of around US $3,500 per...
Apr 24, 2024
On 24 April 2024, the FDA released an updated draft guidance document on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products seeking input from industry by 25 June 2024. The revised guidance...
Apr 24, 2024
On 24 April 2024, Alvotech announced positive topline results from a confirmatory clinical study of AVT05 (golimumab), with the biosimilar demonstrating therapeutic equivalence to Janssen’s Simponi® and Simponi Aria® in patients with moderate to severe rheumatoid...
Apr 24, 2024
On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC) has become publicly available. The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each...
Apr 24, 2024
Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products. Biosimilar highlights for...
Apr 22, 2024
On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab). The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the...
Apr 21, 2024
On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM. The issues identified primarily concern (a) the analytical methods for the reference standard;...
Apr 20, 2024
Dr Reddy’s announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for biosimilar rituximab (DRL_RI), biosimilar to Genentech/Biogen’s Rituxan®. The CRL is said to relate to the ongoing resolution of results of regulatory inspections at...
Apr 19, 2024
On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction...
Apr 19, 2024
On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February...
Apr 19, 2024
On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada's approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen's NEULASTA®. This follows Coherus' launch of Udenyca...
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