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Interviews

Interviews

‘We’ve Got The Broadest Pure-Play Oncology Portfolio In The industry’ – Pfizer Talks Biosimilars

Pfizer is one of the leading players in the global biosimilars market. Barry Chester, the firm’s global commercial lead for supportive care oncology, talks to Generics Bulletin about how the business fits into the firm’s wider interests, in the first part of an exclusive interview.

Biosimilars Strategy

 
Commercial

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

Generic Drugs Launches

Richter Swallows Up Estetrol Franchise And More From Stricken Mithra

Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.

M & A Deals

Dr. Reddy’s Aurigene Unit Opens New Indian Biologics Facility

The Dr. Reddy subsidiary CRDMO Aurigene has opened a new biologics facility in India, with plans to finish the plant’s manufacturing capabilities later this year.

India BioPharmaceutical
See All
Regulation

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Pfizer Calls For Sustainable Approach To Ensure Viability Of Biosimilars Market

Global biosimilars player Pfizer is calling for a more sustainable approach to the market to ensure its long-term viability. In the second part of an exclusive interview, Barry Chester, the firm’s global commercial lead for supportive care oncology, tells Generics Bulletin where the company sees room for improvement.

Biosimilars Strategy

Samsung, Biogen Co-Operate Amid Italian Antitrust Investigation Into Biosimilar Lucentis

Did Samsung Bioepis and Biogen choose early US access for its Lucentis biosimilar in exchange for postponing launch in other global markets? That’s what Italy’s competition authority believes, as it kicked off an investigation into both the biosimilar sponsors and originators Genentech and Novartis.

Regulation Legal Issues

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.

Strategy Generic Drugs
See All
Generic Drugs

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

Generic Drugs Launches

Opioid Overdose Reversal Drug Manufacturers Commit To Increased Naloxone Capacities

Hikma, Teva, and other drug manufacturers have committed to increased supply of naloxone and nalmefene as part of a meeting with the White House Office of National Drug Control.

United States Generic Drugs

Amneal Launches Six Injectables With Some To Aid US Drug Shortage

Amneal aims to address the ongoing drug shortage crisis in the US with injectable additions to its portfolio. Meanwhile, the FDA states that it has “made a significant impact” to mitigate shortages, preventing 236 shortages in 2023.

Generic Drugs Market Access
See All
Generic Drugs

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

Generic Drugs Launches

Opioid Overdose Reversal Drug Manufacturers Commit To Increased Naloxone Capacities

Hikma, Teva, and other drug manufacturers have committed to increased supply of naloxone and nalmefene as part of a meeting with the White House Office of National Drug Control.

United States Generic Drugs

Amneal Launches Six Injectables With Some To Aid US Drug Shortage

Amneal aims to address the ongoing drug shortage crisis in the US with injectable additions to its portfolio. Meanwhile, the FDA states that it has “made a significant impact” to mitigate shortages, preventing 236 shortages in 2023.

Generic Drugs Market Access

UK Pregabalin Prices Skyrocket In May

Pregabalin topped our table of Biggest Risers in May, in another month of multiple treble-digit-percentage average price increases for the UK generics market.

Generic Drugs Pricing Strategies

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.

Strategy Generic Drugs

IGBA Celebrates ICH Re-Election And CEO Committee Progress

In a busy month for the IGBA, the global off-patent industry association has celebrated re-election to the ICH’s management committee and has held a meeting of its own CEO advisory committee.

Generic Drugs Biosimilars

Aurobindo’s Eugia Prepares For ‘Muted’ Growth In FY2025

While Eugia continues to look for ways to solve the future challenges amidst temporary plant closure, parent Aurobindo reported a “good” performance in FY2024, with expected continued growth, and gave an update on its Auro Peptides business and GLP-1s.

Generic Drugs Strategy

France Threatens To Block Servier Sale Of Biogaran To Outside Owner

“We have been very clear with Servier that we do not want it to sell Biogaran,” France’s prime minister has indicated, suggesting that a foreign purchaser would face “drastic conditions” attached to any deal.

Deals M & A

Hikma Opens UK Office To Strengthen Ties With NHS

Just weeks after announcing the establishment of a Spanish subsidiary, Hikma has crossed the English Channel to strengthen its position in Europe by opening a commercial office in the UK.

United Kingdom Generic Drugs

Sun-Taro Merger Nearing Completion As Shareholders Vote Yes

Sun Pharma will finally merge with Taro as a single company, after failed attempts to absorb the firm over a decade ago. Also, the firm hints about its upcoming generic portfolio, including GLP-1 products, as well as increasing investment into its specialty business.

Deals M & A

ANDA Suitability Petitions: The Timelines They Are A-Changin'

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Regulation Generic Drugs
See All
Biosimilars

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Pfizer Calls For Sustainable Approach To Ensure Viability Of Biosimilars Market

Global biosimilars player Pfizer is calling for a more sustainable approach to the market to ensure its long-term viability. In the second part of an exclusive interview, Barry Chester, the firm’s global commercial lead for supportive care oncology, tells Generics Bulletin where the company sees room for improvement.

Biosimilars Strategy

Dr. Reddy’s Aurigene Unit Opens New Indian Biologics Facility

The Dr. Reddy subsidiary CRDMO Aurigene has opened a new biologics facility in India, with plans to finish the plant’s manufacturing capabilities later this year.

India BioPharmaceutical

Alvotech And Stada Are Back With A Denosumab Biosimilar Deal

With an ustekinumab biosimilar launch in Europe just around the corner, Alvotech and Stada have reconsidered the previously dropped denosumab partnership, while commercial rights to the aflibercept biosimilar go back to Alvotech.

Deals Strategy
See All
Value-Added Medicines

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Outlook Sets Out Plans For Ophthalmic Bevacizumab In Europe

Outlook Therapeutics has revealed more details of its European launch strategy for its Lytenava ophthalmic bevacizumab following the product’s formal European Commission approval.

Approvals Launches

What’s Next? Five Things To Look Out For In June

Generics Bulletin previews the most noteworthy and anticipated events for June 2024.

Biosimilars Generic Drugs

Irish Body Calls For Urgent Action To Tackle Drug Shortages

Medicines for Ireland has called for action that would alleviate drug shortages affecting every fifth patient in the country after recently urging strategic reform in the EU.

Biosimilars Generic Drugs
See All
Recent Stories

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

Generic Drugs Launches

Pfizer Calls For Sustainable Approach To Ensure Viability Of Biosimilars Market

Global biosimilars player Pfizer is calling for a more sustainable approach to the market to ensure its long-term viability. In the second part of an exclusive interview, Barry Chester, the firm’s global commercial lead for supportive care oncology, tells Generics Bulletin where the company sees room for improvement.

Biosimilars Strategy

Richter Swallows Up Estetrol Franchise And More From Stricken Mithra

Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.

M & A Deals

Dr. Reddy’s Aurigene Unit Opens New Indian Biologics Facility

The Dr. Reddy subsidiary CRDMO Aurigene has opened a new biologics facility in India, with plans to finish the plant’s manufacturing capabilities later this year.

India BioPharmaceutical

Alvotech And Stada Are Back With A Denosumab Biosimilar Deal

With an ustekinumab biosimilar launch in Europe just around the corner, Alvotech and Stada have reconsidered the previously dropped denosumab partnership, while commercial rights to the aflibercept biosimilar go back to Alvotech.

Deals Strategy

‘We’ve Got The Broadest Pure-Play Oncology Portfolio In The industry’ – Pfizer Talks Biosimilars

Pfizer is one of the leading players in the global biosimilars market. Barry Chester, the firm’s global commercial lead for supportive care oncology, talks to Generics Bulletin about how the business fits into the firm’s wider interests, in the first part of an exclusive interview.

Biosimilars Strategy

Opioid Overdose Reversal Drug Manufacturers Commit To Increased Naloxone Capacities

Hikma, Teva, and other drug manufacturers have committed to increased supply of naloxone and nalmefene as part of a meeting with the White House Office of National Drug Control.

United States Generic Drugs

Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar

Biocon has been handed a further setback in its attempts to launch a biosimilar to the market-leading Eylea in the US, after a US district court signed off on a permanent injunction against the Indian firm lasting until June 2027. Meanwhile, decisions on motions for preliminary injunctions against several other biosimilar sponsors are imminent.

Legal Issues Litigation

Lotus Builds In Southeast Asia With Teva Thailand Acquisition

Lotus will look forward to adding ophthalmic and respiratory products to its growing portfolio after striking a deal to swallow up Teva’s operations in Thailand.

M & A Deals

Amneal Launches Six Injectables With Some To Aid US Drug Shortage

Amneal aims to address the ongoing drug shortage crisis in the US with injectable additions to its portfolio. Meanwhile, the FDA states that it has “made a significant impact” to mitigate shortages, preventing 236 shortages in 2023.

Generic Drugs Market Access

UK Pregabalin Prices Skyrocket In May

Pregabalin topped our table of Biggest Risers in May, in another month of multiple treble-digit-percentage average price increases for the UK generics market.

Generic Drugs Pricing Strategies
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