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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

Coronavirus Spotlight


Coronavirus Spotlight

Dr Reddy’s Gears For Sputnik Light In India, Jab For Adolescents

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.

Coronavirus COVID-19 Strategy

Interviews

Interviews

‘Everything Cannot Be Locally Produced,’ Says IGBA Chair

In an exclusive interview with Generics Bulletin, IGBA chair Sudarshan Jain said that a resilient and diversified supply chain is critical, but localized production may not be the answer to everything. IGBA secretary general Suzette Kox and Jain discussed key lessons to be learned from COVID-19, the IGBA’s focus on regulatory harmonization, and challenges in driving the adoption of generics, biosimilars and value-added medicines.

International Biosimilars

OUTLOOK 2021

In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies


VIEW 2021 RANKINGS

Final Days See Entries Surge For GGB Awards

Entries are accelerating for the Global Generics & Biosimilars Awards 2021 being held on 10 November, as off-patent industry players from around the globe seek to submit their achievements for consideration ahead of the 30 July deadline.

Generic Drugs Biosimilars Value-Added Medicines
 

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Dr Reddy’s Gears For Sputnik Light In India, Jab For Adolescents

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.

Coronavirus COVID-19 Strategy

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

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

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

Viatris Still Exploring Alternatives For Morgantown Plant As Closure Looms

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.

Manufacturing Strategy

Sun Strikes Deal For Clascoterone In US And Canada

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.

United States Canada
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Policy & Regulation Explore this Topic

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ANDA Approval Decline Continues, But Why?

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

Generic Drugs Review Pathway

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

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

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

FDA Refuses To Budge On Nitrosamines Compliance

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

Quality Compliance

AAM Says Seniors Are Missing Out On Medicare Savings

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.

United States Generic Drugs
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Generic Drugs Explore this Topic

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ANDA Approval Decline Continues, But Why?

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

Generic Drugs Review Pathway

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
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Biosimilars Explore this Topic

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
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

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

Advanz Claims A First With German Lanreotide Launch

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.

Launches Generic Drugs

Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China

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.

Biosimilars Value-Added Medicines
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