Industry

Generics and Biosimilars

Generics and biosimilars, the generic versions of biopharmaceuticals, are having a major impact on the present and future of the pharmaceutical industry. The mass introduction of generics for some of the best-selling branded drugs has forced pharmas to reduce workforce, find and develop new markets, and partner or merge with former competitors. The FDA is developing an approval pathway for biosimilars.

Top Generic Drug Companies
Pharmaceutical companies capturing the greatest share of the global generic drug market.

2012 Renewal of the Prescription Drug User Fee Act (PDUFA)
The proposed re-authorization of the act, PDUFA V, includes new provisions for generic and biosimilar user fees.

Are Pay-for-Delay Settlements History?
Those that want the process stopped say the pay-for-delay agreements violate federal antitrust laws.

Generic Drug Launch Pitfalls
Things that can (and do) go wrong with generic launches.

Generic Drug Pipeline
Numerous new generic drugs are scheduled to enter the marketplace as legacy drugs lose market protection.

PhRMA Testimony on FDA Approval Pathway for Biosimilars
Pharmaceutical Research and Manufacturers of America (PhRMA) testimony on FDA public hearing on federal implementation of the new biosimilars approval pathway.

ANDA (Generic) Drug Approvals
FDA page for searching generic drug approvals and tentative approvals

Generics and Biosimilars Initiative (GaBI)
A source of news and other resources in the generics/biosimilars industry.

Generic Pharmaceutical Association (GPhA)
Represents U.S. generic pharmaceutical manufacturers and distributors

European Generic Medicines Association
Represents generic and biosimilar pharmaceutical industry and consults on European health care policy.

Generic Drugs
Generic drugs overview

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