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Policy and Regulation

Regulation Explore this Topic

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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

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
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Pricing Strategies and Reimbursement Explore this Topic

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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

‘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

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

UK Generic Price Spikes Ease In April

With UK shortages and price rises making headlines in early 2024, April’s generic pricing data suggested an easing of pricing increases, according to the latest figures from WaveData.

Market Intelligence Generic Drugs
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Intellectual Property Explore this Topic

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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

Key UK Xarelto Patent Knocked Out Again In Boost For Generics Manufacturers

Bayer has been left reeling after the UK Court of Appeal found in favor of generics manufactures and reaffirmed a decision to revoke a key patent shielding its blood-thinner blockbuster Xarelto (rivaroxaban). Challenges to Xarelto’s IP are continuing apace across Europe.

Legal Issues Intellectual Property

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

We take a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

AAM Backs FDA’s Proposal For Skinny-Label Safe Harbors

AAM expressed its support for the FDA’s attempt to protect generics and biosimilar companies and their products with skinny labels that carve out patented indications. Meanwhile, the Senate Committee’s hearing on drug pricing gets mixed opinions.

Intellectual Property Legal Issues
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Market Intelligence Explore this Topic

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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

UK Generic Price Spikes Ease In April

With UK shortages and price rises making headlines in early 2024, April’s generic pricing data suggested an easing of pricing increases, according to the latest figures from WaveData.

Market Intelligence Generic Drugs

Taking European Biosimilars To The Next Level

Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.

Biosimilars Europe

Cigna Move Offers More Good News For US Humira Biosimilars

Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.

Biosimilars Market Intelligence
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