Members of the BRICS organization, which includes countries such as Brazil, Russia, India, China, South Africa, Saudi Arabia, Iran, Egypt, Ethiopia, and the United Arab Emirates, have gathered together to talk about a unified goal – creating their own market for biosimilars.
Regulatory Recap: BRICS Countries Discuss Building Independent Market For Biosimilars
Also, Regulatory Updates From The FDA, IGBA, And The Philippines
Generics Bulletin recaps the most recent regulatory news from across the world.
More from Regulation
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The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Echoing wider sentiments in the biosimilar and generic drug industry, the IGBA has warned of the potential consequences of mercantilist tariffs on the global drug supply and their impact on industry and patients.
More from Policy & Regulation
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Alvotech and Advanz have announced a UK MHRA filing acceptance for their partnered AVT23 proposed biosimilar to Xolair (omalizumab).
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Optum Rx, one of the largest PBMs in the US, declared itself as the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
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As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.