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Strategy
Huge opportunities for OTC therapies loom in India, as consumerization brings structural reset in healthcare. Success stories on Rx-to-OTC transition augur well for pharma, but a predictable regulatory roadmap will be pivotal for sustainable growth.
Huge opportunities for OTC therapies loom in India, as consumerization brings structural reset in healthcare, as per a new report by EY-Parthenon. Success stories on Rx-to-OTC transition augur well for pharma, but a predictable regulatory roadmap will be pivotal for sustainable growth.
‘It’s A Great Opportunity But It’s Also Late’ – Samsung Bioepis’ Woollett On Biosimilar Streamlining
Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.
Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.
Even though the ink has long dried on the US-South Korea trade deal, new threats have prompted Celltrion to reiterate its “fundamental solution” to tariff concerns.
Dr Reddy’s gears for semaglutide debut across markets, including India and Canada, where Novo Nordisk has second brands of the GLP-1 agonist potentially ready. Can the Indian group close out compliance queries from the Canadian regulator soon?
With the separation from its parent company now behind it, Samsung Bioepis celebrated its highest-ever annual revenues and outlined its vision of further growth.
In line with previously disclosed launch and partnering plans for GLP-1 products, Lupin shook hands with Galenicum, securing commercial rights to injectable semaglutide.
As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.
The Swedish biotech's LIB-01 offers eight-week efficacy from three-day dosing, targeting high discontinuation rates with current PDE5 inhibitors.
Generics Bulletin reviews global regulatory developments across the world.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.