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Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts
As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…
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Sandoz has launched Pyzchiva, a biosimilar version of Stelara in the US to treat mod. to sev. plaque PsO & active PsA in adults as well as pediatric pts, plus mod. to sev. active crohn’s disease & UC in adults; expected to offer interchangeability by H1'25
Launch follows Samsung’s settlement & license deal…
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The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25
Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine
Aflibercept is a…
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Known for delivering the same therapeutic benefits as its brand-name counterpart, it won't be an exaggeration to refer to generic drugs as modern-day advocates for health equity
In 2022, the global market size of generic drugs was valued at $411.99B and is envisioned to reach $613.34B by 2030 with a CAGR of 5.10%. Sandoz…
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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
The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
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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…
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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…
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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.…
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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.…

