Shots:Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for CanadaThe agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturingBAT2506 is an IgG1 monoclonal antibody that targets…
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: Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…
Shots:FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
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 Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…
Shots: Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab) As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…
Shots:Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US
As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones
BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…
Shots:The EMA has accepted the MAA of BAT2506, a biosimilar version of Simponi (golimumab)
Approval was backed by extensive analytical characterization and biosimilarity of BAT2506 in comparison to US & EU golimumab from P-I trial in healthy subjects, plus P-III trial (vs. EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable…
Shots: Bio-Thera and STADA have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) Under the collaboration, Bio-Thera is entitled to receive a $10M upfront and an additional $147.5M development and commercial milestones upon certain conditions fulfilment Furthermore, Bio-Thera will handle the development, manufacturing and supply activities of…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyCadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar)Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 20201. Samsung…

