Reports
Challenges in implementing trials to prove interchangeability
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act the agency published draft guidance on biosimilar interchangeability in January 2017 [1].
EU report finds decline in pay-for-delay pharma deals
The European Commission (EC) published the 8th Report on Monitoring Patent Settlements. It covers the 107 pharmaceutical patent settlements concluded between originator and generic drug companies in 2016 and shows that pay-for-delay settlements continue to decline. Such settlements can contravene antitrust laws with originator manufactures paying-off generics companies to delay generics market entry. Pay-offs can be monetary, but may also include distribution or licensing agreements or restrictions.
Interchangeability for biosimilars
Dr Daniel F Alvarez, Senior Director at Pfizer, gave a presentation on interchangeability for biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25 October 2017 in Bethesda, Maryland, USA [1].
FDA approach to retrospectively naming biologicals
How the US Food and Drug Administration’s (FDA) is tackling retrospective naming of biologicals was an issue covered by Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research (CDER). Dr Taylor gave an update on FDA’s naming policies for biologicals, including biosimilars [1].
FDA approach to prospectively naming biologicals
During her presentation at the Drug Information Association’s (DIA) Biosimilars Conference, Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER), gave an update on FDA’s naming policies for biologicals, including biosimilars [1].
FDA update on naming biologicals
Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), gave an update on the agency’s naming policies for biologicals/biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25 October 2017 in Bethesda, Maryland, USA [1].
Lack of confidence in biosimilars slowing uptake in the US
Lack of confidence is amongst the various obstacles causing slow uptake of biosimilars in the US.
Legal and promotional wars being waged against biosimilars
Several obstacles contribute to the slow uptake of biosimilars in the US, one of which is the legal and promotional wars being waged against biosimilars by originator companies.
Biosimilars pricing slowing uptake in the US
Researchers at Trinity Partners have identified three major obstacles that are slowing the uptake of biosimilars in the US. These include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars. In this article biosimilars pricing is discussed.
Obstacles to biosimilars uptake in the US
Biosimilars uptake in the US has been slow to say the least, but what are the reasons for this? Researchers at Trinity Partners have come up with three major obstacles to increasing uptake of biosimilars in the US.
