We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search

Clear all

Refine your search

Content type

Tags

Firm name

Author

Language

1,566 results found

Article

LexOrbis | India | 22 Jun 2019

Biosimilars- An emerging trend in Indian Pharma industry

India released the draft regulatory guidelines for ‘Similar Biologics’ at the BIO industry conference in Boston, USA, on 19 June 2012. These

Article

Bereskin & Parr LLP | Canada | 28 May 2019

Canadian Provincial Governments Actively Redirecting Patients to Biosimilar Drugs to Save Money

Biologics are drugs which contain an active medicinal ingredient that is derived from living cells. They are generally proteins, which are larger and

Article

Hogan Lovells | USA | 15 May 2019

FDA guidance may ease path to biosimilar interchangeability

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to

Article

Covington & Burling LLP | European Union | 19 Apr 2019

This Week in the European Parliament- April 19, 2019

This week was the last Plenary session of this Parliament. The Parliament finalized most of its pending initiatives before the elections in May.

Article

Haynes and Boone LLP | USA | 29 Mar 2019

It’s All in the Name: Updated FDA Guidance on Nonproprietary Naming of Biologic Products

In January 2017, the FDA published guidance that adopted a naming convention that attaches a distinguishing suffix to the proper names of both

Article

NautaDutilh | European Union | 27 Mar 2019

European SPC Waiver for Export and Stockpiling of Generics and Biosimilars

On 14 February 2019, the Committee of the Permanent Representatives of the Governments of the Member States (Coreper) endorsed a draft regulation

Article

K&L Gates | USA | 21 Mar 2019

The Federal Circuit Dismisses Biosimilar Petitioner’s IPR Appeal for Lack of Standing Due to Mootness

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed a biosimilar petitioner's appeal of an adverse inter

Article

Finnegan, Henderson, Farabow, Garrett & Dunner LLP | USA | 20 Mar 2019

FDA Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351 of the PHS Act

On March 7, 2019 FDA updated the Center for Drug Evaluation and Research (CDER) Manual of Policies on Procedures (MAPP) for Nonproprietary Naming of

Article

Smart & Biggar | Canada | 20 Mar 2019

Health Canada announces decision on naming of biologic drugs

Following its stakeholder consultations and analysis of issues relating to the name of biologic drugs, including biosimilars, Health Canada recently

Article

Quarles & Brady LLP | USA | 19 Mar 2019

The President’s 2020 Budget Keeps 340B Program in the Spotlight

On March 11, 2019, the President delivered his proposed 2020 budget to Congress. While a President’s budget proposal is the beginning of a lengthy

Previous page 1 2 3 ...