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Biosimilars

Set Alert for Biosimilars

Teva Likes Biosimilar Licensing Deals As It Cuts Full-Year Sales Guidance

Teva is keeping a keen eye out for opportunities like its US biosimilars agreement with Alvotech and more recent deal with Bioeq for biosimilar Lucentis as it attempts to maintain revenues in the coming years, following a cut to full-year sales guidance for 2021.

Sales & Earnings Strategy

GGB Awards Offer One More Week To Enter

Off-patent industry players from around the globe now have an extra week to submit their achievements to the Global Generics & Biosimilars Awards 2021 being held on 10 November, after the entry deadline was extended by a week to 6 August. Pharmacloud has also joined the event, sponsoring the Leader of the Year category.

Generic Drugs Biosimilars

Pfizer Takes ‘Opportunistic’ Approach To Future Biosimilars

Pfizer reported double-digit growth in its biosimilars and sterile injectables segments, as the company indicated that it would take a more “opportunistic” approach to its biosimilars business in future. The company has also revised its overall 2021 financial guidance as it expects better numbers on the back of its COVID-19 vaccine business.

Biosimilars Coronavirus COVID-19

Viatris Wins Landmark First US Interchangeability Designation For Semglee

Viatris has revealed its commercial strategy for its Semglee insulin glargine biosimilar in the US after winning a landmark first designation of interchangeability for the product from the FDA that will allow pharmacy-level substitution with a year of exclusivity.

Biosimilars Approvals

BioXpress And Abzena Partner On Biosimilar Development

BioXpress Therapeutics and Abzena, two service providers with expertise in biosimilar development, have partnered to support biosimilar development for third party customers. The companies plan to offer a “flexible and innovative approach from small scale biosimilar development through to large scale manufacturing.” 

Biosimilars Deals

FDA Rebates Biosimilar Fees And Limits Generic Fee Hike

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

User Fees Generic Drugs

Industry Ready To Embrace Digitalization, Says IGBA

IGBA chair Sudarshan Jain has indicated that "companies are undergoing the change towards digital health," in the second part of an exclusive interview with Generics Bulletin in which Jain and IGBA secretary general Suzette Kox talk about the pandemic-driven shift towards digitalization and computerization.

Digital Health Biosimilars

Biocon Waits On FDA Insulin Inspection

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Biosimilars Sales & Earnings

Roche Battered By Biosimilars But Holds On To Initial Forecast

Roche insisted that “biosimilar competition is only one factor in the overall picture,” as it reported another set of depleted figures for its three powerhouse biologic brands: Avastin, MabThera/Rituxan and Herceptin.

Biosimilars Sales & Earnings
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