29 APR 2024 | KR | Samil Pharmaceutical to Launch Samsung Bioepis’ Aflibercept in Korean Market from 1 May
The Korean Biomedical Review has reported that Samil Pharmaceutical wil...
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By Naomi Pearce, Chantal Savage, Faran Shahzad | Apr 29, 2024
29 APR 2024 | KR | Samil Pharmaceutical to Launch Samsung Bioepis’ Aflibercept in Korean Market from 1 May
The Korean Biomedical Review has reported that Samil Pharmaceutical wil...
By Bioblast Editor | Apr 29, 2024
The Korean Biomedical Review has reported that Samil Pharmaceutical will launch Samsung Bioepis’ aflibercept in Korean market from 1 May 2024. Samil and Samsung Bioepis entered into a B2B commercialisation deal for biosimilar aflibercept in February 2024, following their a...
By Bioblast Editor | Apr 29, 2024
On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.
The following biosimilars have been recommended for listing on the Pharmaceutical Benef...
By Bioblast Editor | Apr 25, 2024
On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche’s RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP). The recommendation relates to the IV formulation of tocilizumab for t...
By Bioblast Editor | 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 injectio...
By Bioblast Editor | 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 year ....
By Bioblast Editor | 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On 24 April 2024, the FDA released an updated draft guidance document on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products seeking input from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 large...
By Bioblast Editor | 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 arthritis....
By Bioblast Editor | 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 ...
By Naomi Pearce, Chantal Savage, Faran Shahzad | Apr 22, 2024
21 APR 2024 | US | Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL
On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Compl...
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