Regulatory

The biologic has the potential to deliver effective treatment for adult patients with generalized myasthenia gravis, but it comes at a high cost.

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 23.

A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

Drug prices in several disease areas outpace other healthcare expenditures and result in inadequate availability of essential medicines globally, according to a recently published review.

In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 16.

While no one argues that orphan drugs that treat rare diseases can be expensive, the drugs’ reputation for being budget-busters is not borne out by a data presented in a recent report by Quintiles IMS Institute.

Nichi-Iko has disclosed that it is currently engaged in consultations with the FDA concerning the demonstration of interchangeability of its proposed biosimilar with the reference Remicade.

Who will be the first manufacturer to succeed in gaining European or United States regulatory approval for a biosimilar pegfilgrastim product?

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

After having warned that it could lose up to 94% of its staff in a relocation from its current home in London, United Kingdom, The European Medicines Agency (EMA) this week revealed its top location choices for the agency’s upcoming move.

A European study published this week finds that, at a minimum of 3.3 years after market entry, there was no conclusive evidence that many oncology drugs approved by the European Medicines Agency between 2009 and 2013 either extended or improved life in most oncology indications.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 2.

The Federal Trade Commission (FTC) has announced a November 8 workshop that will focus on competition issues related to prescription drug marketing.

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

In the first week of October, FDA Commissioner Scott Gottlieb, MD, announced 2 new initiatives intended to make drugs more widely available: the first is designed to help developers of complex generics better navigate the approvals process, and the second aims to streamline access to investigational treatments for compassionate use.

The FDA’s Adverse Event Reporting System Public Dashboard, a new, user-friendly tool available to search the FDA’s adverse event database for drugs and biologics, has been launched.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.