Dosage Forms

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Articles

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

Biosimilars Market will be Worth $3.7 Billion by 2015

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

Next Steps for the US Biosimilar Regulatory Scheme

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Quality by Design for Biologics and Biosimilars

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do Where Go From Here?

Nathan Jessop is a columnist for Pharmaceutical Technology Europe.

The recent India–EU summit was expected to bring news about the upcoming Free Trade Agreement between the EU and India; however, a dispute regarding the supply of generic drugs from India to developing countries has taken centre stage.

Generics Dispute EU-India Trade Negotiations

Dishman is giving a step further in its strategy to manufacture high potency (HiPo) Active Pharmaceutical Ingredients (APIs).

Dishman to enter high potency generics' market

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

Regulatory Roundup: EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

Regulatory Roundup: FDA Holds Biosimilars Public Hearing

Angie Drakulich was editorial director of Pharmaceutical Technology.

Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.

Biosimilars Hearing Begins Today

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

Generic Drugs