The US approach to biosimilars explained

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Cookies Settings

The US approach to biosimilars explained

February 15 2012

The FDA’s draft guidance for biosimilars has provided some clarity for biosimilar applicants and innovator biologic companies. But lawyers say many questions remain

Unlock this content.

The content you are trying to view is exclusive to our subscribers.

To unlock this content:

Take a Free Trial or Login

Topics

United StatesNewsPatentsNorth AmericaJurisdictions
more from across site and SHARED ros bottom lb

More from across our site

Patents
Electronic circuit board close up.
Via LA unveils plans for semiconductor patent pool
The patent pool operator is launching new offerings covering semiconductor technologies amid the rapid adoption of AI and tech
Sanjana Mishra, September 25 2025
Patents
Hands Holding a Young Plant in Healthy Soil
CTRs for plant protection products: a global view
Achim Krebs of HGF and Flip De Corte of Syngenta provide an overview of compensatory term rights for plant protection products around the world
Filip de Corte, September 25 2025
Patents
Australia on globe.jpg
Why Australian computer patent ruling raises hopes
A Full Federal Court ruling on the patent-eligibility of computer-implemented inventions in Australia could pave the way for more filings
Sukanya Sarkar, September 25 2025
Patents
Modern laundry room with multiple washer dryers
UPC update: washing machines, refunds and a new CMS
In major recent developments, the court ruled in a dispute over washing machines, issued a reimbursement decision, and the Munich Division welcomed a visit from EU officials
September 25 2025
Patents
quantum.jpg
Quantum computing: risks, opportunities and challenges in the next technological epoch
Oliver Yaros, leader of Mayer Brown's London IP practice, explains what IP practitioners need to consider
Oliver Yaros, September 24 2025
Patents
pattern with people
Weekly take: Why DEI is not just a tick box exercise
Cassandra Hill of Mishcon de Reya explains why the firm remains committed to diversity targets and why others should follow suit
Cassandra Hill, September 24 2025
Trademarks
acquisition.jpg
Com Laude to acquire Markmonitor in $450m valued deal
UK-headquartered Com Laude, which provides domain name-related services, says the deal will mark a ‘transformative combination’
September 24 2025
Features
Globe with connections between countries
IP Service World 2025: insights, innovation, and global collaboration
International intellectual property experts will be addressing AI, the Unified Patent Court, monetisation strategies, and more at the event in Munich in November
September 23 2025
Patents
MarianaSabido-43.jpg
NLP co-founder: why litigation ‘adrenaline burst’ tests patience and preparation
Beatriz Lima joins us for our ‘Five minutes with’ series to discuss a recent victory at the Unified Patent Court and the challenges of establishing your own firm
September 23 2025
Patents
Burr Eckstut.jpg
HSF Kramer eyes complex IP deals with post-merger hire
Former White & Case partner joins HSF Kramer’s New York office to head up US technology transactions practice and strengthen firm’s IP and tech capabilities
Sanjana Mishra, September 23 2025
Gift this article