Shots: Generic medicines play a pivotal role in offering cost-effective alternatives to high-priced pharmaceuticals. They often serve as a critical lifeline in developing and underdeveloped nations, helping to address both chronic and infectious diseases. In 2024, the global generics market was valued at $445.62B, with projections to reach approximately $468.08B in 2025 and ~$728.64B by…
Shots:Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the USIn Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for…
Shots:Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar version of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditionsAs per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…
Shots: Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…
Shots:Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the USAs per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestonesTofidence is a humanized…
Shots: The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19 The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…
Shots: The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab) According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates Tyenne functions as an Interleukin-6 (IL-6) receptor…
Shots: The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA) Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patientsDuring the month of September, Sandoz entered into a development and commercialization agreement…
Shots:Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritisHe briefed about the study design and results from the P-III trial which supported the BLA filingThis interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…

