Content about Biosimilar

ST. LOUIS — Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

President Barack Obama sent his $3.8 trillion budget proposal to Congress on April 10, and the plan includes a number of provisions designed to cut spending on health care and promote health and wellness.

Overall, the budget is something of a mixed bag for the healthcare industry. While it would provide incentives for expanding the use of generic drugs, for example, it would also cut spending on Medicaid that have drawn opposition from pharmacy retailers, and even generic drug makers disagree with some of its provisions for that industry.

WASHINGTON — Legislation designed to limit the use of biosimilars has met defeat in Maryland.

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

A new bill (HB 365) in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports. The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years. A similar bill (SB 732) is pending in the Florida Senate, according to reports.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

WASHINGTON — Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

The Generic Pharmaceutical Association called for measures to lower healthcare costs, including ensuring that generic pharmaceuticals and biosimilars reach patients' hands quickly and also avoiding measures intended to provide savings that the GPhA said would raise prescription drug costs, though the grow didn't specify what those measures were.

NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.