Celltrion has received a positive opinion from the CHMP for five additional indications for its Remsima SC biosimilar, expanding the scope of the subcutaneous infliximab product that was launched earlier this year.
Celltrion will be able to expand the scope of treatment for its innovative subcutaneous formulation of biosimilar infliximab after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending an additional five indications for Remsima SC, including for use in inflammatory bowel disease and ankylosing spondylitis.
The European Commission typically acts to convert CHMP recommendations into formal approvals within 67 days.
As Alvotech announced first-half results that outpaced expectations, the biosimilars developer’s management explained that the firm was targeting value and product margin over market share and volumes.
Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
With H1 revenues not even hitting double-digits, Formycon is bidding on partnerships and royalties to generate at least €46m over the next half-year to reach its revenue goal.
Shortly after filing its lead candidate for ADHD through the FDA’s 505(b)(2) hybrid new drug application pathway, Cingulate has appointed interim leadership after placing chairman and CEO Shane Schaffer on administrative leave over legal matters unrelated to the company.
Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
