No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
May 1, 2024
On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie's Humira® (adalimumab)), for multiple chronic inflammatory diseases. BI now has approvals for the high (100 mg/mL)...
Apr 30, 2024
On 30 April 2024, Alvotech announced a strategic partnership with Quallent Pharmaceuticals Health, under which a high-concentration interchangeable biosimilar to Humira® manufactured by Alvotech will be distributed under Quallent’s private-label. This partnership...
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...
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...
Apr 29, 2024
On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma. This is the...
Apr 29, 2024
On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances. This concludes...
Apr 27, 2024
A paper published in the Journal of the American Academy of Dermatology on 27 April 2024 reported that, in a Phase 3 clinical trial sponsored by Samsung Bioepis, SB17 (ustekinumab) was biosimilar to Janssen’s Stelara® (in terms of efficacy, safety, pharmacokinetics,...
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...
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...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.