News & Analysis as of

Regulatory Requirements Patent Litigation Prescription Drugs

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

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