Dr Reddy’s is to press ahead with India filing plans for single-dose COVID-19 vaccine Sputnik Light and also expects to “build on” the Russian partner’s trial in adolescents of the two-dose Sputnik V. The company also pilots a partnered first-of-its-kind cashless digital health offering.

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.

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.

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.” 

The end of July will bring the closure of Viatris’ Morgantown plant, following years of compliance issues for the once flagship Mylan facility. But the company has revealed that it is still in the process of exploring alternatives for the site outside of Viatris.

Sun Pharma has expanded its dermatology portfolio by entering into a partnership with Italy’ Cassiopea to market Winlevi (clascoterone) 1% cream in the US and Canada, and expects to make it available in the US inthe fourth quarter of 2021.

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

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.

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.

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.

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

The AAM’s latest study reveals that the Medicare Part D program continues to underperform compared to commercial plans in providing patients with access to generic medicines. The industry association has also urged policymakers to modernize Medicare Part D.

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

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.

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.

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.

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.

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.

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.

Advanz has claimed a first with a European launch of a rival to Ipsen’s Somatuline, introducing its generic lanreotide in Germany under the name Mytolac.

Sorrento and Mabpharm have revealed plans to take their infliximab “biobetter” global, after China’s NMPA approved the product, which has an improved safety profile compared to Remicade.