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Taylor Wessing | Austria, United Kingdom, France | 28 May 2013

Reimbursement of biosimilars

Improvements in technology and pressures to diversify business models away from small molecule drugs are just two of the factors that are focussing


Dechert LLP | India | 16 Jul 2012

India's new biosimilar guidelines and their relationship to the rest of the world

The Indian Ministries of Health & Family Welfare and Science and Technology have released their Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India (the “Indian Guidelines”).


Shook Hardy & Bacon LLP | USA | 1 Mar 2012

News bytes

The Food and Drug Administration (FDA) releases a final guide dated February 2012 titled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.”


Jones Day | USA | 15 Feb 2012

FDA issues draft guidance for demonstrating biosimilarity

Biological productsa category that includes proteins, such as antibodies, vaccines, blood products, and serumsare becoming increasingly important in the treatment of disease.


Fish & Richardson | European Union | 16 Nov 2011

The EMA's 2005 general guidelines on biosimilarity

The EMA’s initial guidance on biosimilarity, the so-called “overarching guidelines,” adopted in 2005, introduced the general approach for development and approval of biosimilar products.


Piper Alderman | Australia | 7 Jun 2011

Regulation and PBS pricing of biosimilar drugs

In this article, we examine the issues surrounding the regulation of biosimilar drugs in Australia, including pricing issues under the Pharmaceutical Benefits Scheme.


Shook Hardy & Bacon LLP | USA | 18 Nov 2010

Stakeholders provide input on FDA review standards for biosimilars

The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics).


Morgan Lewis | USA | 19 Apr 2010

Healthcare reform law: a new regulatory pathway for biosimilar biological products

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), establishes an abbreviated licensure pathway for biosimilar biological products, with provisions covering exclusivity periods, and payment for biosimilars.


Baker & Hostetler LLP | USA | 19 Mar 2009

Generic biotech drug bill introduced in the HouseSenate version to follow shortly

Reps. Waxman, Frank Pallone (D-N.J.), Nathan Deal (R-Ga.) and Jo Ann Emerson (R-Mo.) introduced a bipartisan bill (H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act") that would give the Food and Drug Administration (FDA) authority to approve generic versions of biological drug products.


Dentons | USA | 16 Mar 2009

Bill to allow biosimilars introduced in the House

A bill that would allow the Food and Drug Administration (FDA) to approve similar versions of already-approved biologic drugs was introduced on March 11, 2009, by House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.), and Reps. Frank Pallone (D-N.J.), Nathan Deal (R-Ga.), and Jo Ann Emerson (R-Mo.).

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