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Regulation

Set Alert for Regulation

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

Teva Launches First-Ever CREATES Act Suit

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Legal Issues Generic Drugs

BGMA Emphasizes Benefits Of Competition After UK Hydrocortisone Fines

UK off-patent industry association the BGMA has responded to recent fines issued by competition regulator the CMA over illegal deals for hydrocortisone, highlighting the benefits of functioning generic competition as well as urging improvements to the UK’s pricing and reimbursement system to better recognize situations where supply is limited.

Pricing Strategies Regulation

AAM Calls For A Balance Instead Of Banning Pay-For-Delay

US President Joe Biden has signed an executive order asking the FTC to ban so-called “pay-for-delay” reverse-payment settlements. According to the order, this could help curb high prices that are in part the result of lack of competition among drug manufacturers. However, talking exclusively to Generics Bulletin, AAM senior vice president Jeff Francer insists on a balance, explaining that such settlements result in earlier access to biosimilars and generics.

United States Deals

Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion

Amgen has been rebuked by the FDA over promotion for its unique Neulasta Onpro on-body injector version of pegfilgrastim, in which the firm made false or misleading claims about its benefit compared to a pre-filled syringe formulation of pegfilgrastim, where biosimilar competition exists.

Biosimilars United States
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