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…
SShots:The P-IV (PEARL) study (N=1140) evaluating fremanezumab met its 1EP and 2EPs, demonstrating long-term effectiveness over two years, significantly reducing the frequency, duration, and severity of migraine attacks in both chronic and episodic migraine ptsThe study met 1EP of ≥50% reduction in MMD within the first 6mos. of treatment. Injection adherence remained high…
Shots:Teva & Fosun Pharma have partnered to advance the development of TEV-56278 in immuno-oncology & accelerate global clinical data generationAs per the deal, Fosun will receive an exclusive license to develop, manufacture & commercialize TEV-56278 in mainland China, Hong Kong SAR, Macau SAR & Taiwan as well as select Southeast Asian countries, while…
Shots:Teva & Samsung Bioepis have launched Epysqli, a biosimilar version of Soliris (eculizumab) in the US to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) & generalized myasthenia gravis(gMG) in AchR antibody-positive adultsEpysqli was approved by the US FDA in Jul 2024 for PNH & aHUS, with a label expansion to gMG in…
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 A major highlight was the Samsung Bioepis & Teva Partners to Commercialize…
Shots:Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US
The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…
Shots:The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25
AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…
Shots:Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US
Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar…
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 A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…
Shots:The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25
Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

