Shots: The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…
Shots: Followed by HC’s approval in Aug 2022, Lupin with its partner Sandoz launched Rymti (biosimilar, Enbrel) in Canada The study showed that Rymti has equivalent safety and efficacy to Enbrel. It is a solution for injection in the form of a pre-filled pen & pre-filled syringe Rymti is intended to treat children and…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars 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 patients During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…
Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars 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 patients During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti.…
Shots:The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3BThis quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…
Shots: Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk…
Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars 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 patients During February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics…
Shots: Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
Shots : Sandoz has introduced Tyruko (natalizumab), biosimilar of Tysabri for the treatment of r/r multiple sclerosis (RRMS), in Germany which will be available from Feb 1 Polpharma Biologics is responsible for the development, manufacturing and supply of Tyruko while Sandoz holds its commercialization rights in all markets as per a global commercialization agreement signed…

