The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications.
As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.
Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.
Pharmacists in Pennsylvania may soon be required to notify physicians prior to substituing a biologic medicine with a biosimilar medication following the passing of a bill by the Pennsylvania Senate, the Associated Press reported Tuesday.
The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.
The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.
The pace of annual global spending on oncology medicines — which is approaching the $100 billion threshold — has moderated over the past five years, even as a surge in innovative and targeted therapies has brought new therapeutic options to the growing number of patients being treated for cancer and as survival rates for most tumor types continue to increase, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics.
The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.
Sales of specialty medicines are shifting toward hospitals and specialty pharmacies and away from independent physician owned-and-operated clinics, according to a report released Tuesday by HDMA's non-profit research foundation, The Center for Healthcare Supply Chain Research.
Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.
From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.
The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.
The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.
Actavis on Friday announced a realignment of its global strategic business structure to maximize the company's newly strengthened position as a leading specialty pharmaceutical developer, manufacturer and marketer, and to enhance Actavis' position for continued long-term growth.
The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week.
The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.