Biosimilars Forum Launches Education Initiative

February 8, 2016

On February 1, 2016, the Biosimilars Forum, a nonprofit organization dedicated to increasing biosimilar access in the US, announced the launch of “Partnership for Biosimilar Education and Access,” a new education initiative focused on raising awareness and encouraging access to biosimilars in the US.

In support of the initiative, the Forum has already “released two educational guides designed for health care professionals, media, and patient advocacy organizations to learn more about biosimilars”. Furthermore, using its “vast expertise on the science, development, manufacturing, regulation, and clinical applications of biological medicines and biosimilars,” the education tools provided by the Forum’s initiative are said to offer detailed background, insights, FAQs, and resources on biosimilars.

Juliana Reed, the Biosimilar Forum’s president, stated in a press release that the best treatments for some of the most difficult diseases in the US are biological medicines; and, she claims that “the introduction of biosimilars is anticipated to help drive lower cost burdens for the U.S. health care system. It will also help expand earlier, more consistent access to these important medicines for patients with cancer, anemia, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn's and other inflammatory bowel diseases.”

The information associated with the Forum’s Partnership for Biosimilar Education and Access initiative is free and can be found on the Biosimilar Forum website.

Do you have a biosimilar product in development? Are you in the process of developing a BLA submission for your biosimilar product? We can help. To learn more about our services and our proprietary approach to FDA, contact us today.



Agency Alerts General Regulatory

July 19, 2017

FDA Issues Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies, Requests Comments

On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this...

Read the Full Article
Agency Alerts General Regulatory

July 8, 2016

Federal Circuit Court Requires Biosimilar Makers Participate in “Patent Dance” & Give 180-Day Notice

On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors...

Read the Full Article
Agency Alerts General Regulatory

June 14, 2016

FDA Clarifies Regulations Regarding How Patients May Be Charged for Investigational Drugs

On Thursday, June 2nd the FDA issued a final guidance, entitled “Charging for Investigational Drugs Under an IND — Questions and Answers.” The guidance provides information concerning the...

Read the Full Article