Dosage Forms

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Generic Opioids Create Policy Issues

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Physician Groups Band Together on Labeling of Biosimilars

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.

Fight Over Biosimilar Naming Continues

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

FDA Releases Q&A on Biosimilars

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Court Blocks First FDA-Approved Biosimilar, for the Time Being

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

Biosimilar Giants Launch Biosimilars Forum

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Biosimilars Will Bring Significant Litigation and Patent Challenges

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

FDA Releases Final Biosimilar Guidance

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Generic Drugs