PHARMACY

Florida Senate committee passes biosimilar bill

BY Alaric DeArment

WASHINGTON — A committee of Florida’s state Senate has passed a bill that could limit the use of biosimilars in the state.

The Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law last month by Virginia Gov. Bob McDonnell.

Like the Virginia law, the bill in Florida has a five-year sunset clause stating it will expire in July of the fifth year after the Food and Drug Administration’s approval of a follow-on biologic as interchangeable with a branded biologic.

The legislation received support from the Biotechnology Industry Organization, a Washington-based trade group representing biotech companies.

"Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and different manufacturing processes will rarely, if ever, be exactly the same, hence the name ‘biosimilar,’" a statement from BIO in response to the legislation read.

 

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c.lanski says:
Apr-13-2013 04:57 pm

It's a step in the right direction, even though much remains to be done regarding information regarding actual biological boundaries. Chris Stevens Swiss info travel

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FDA grants tentative approval to Aurobindo HIV drug

BY Alaric DeArment

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences’ Atripla.

Tentative approval means that the drug meets the FDA’s requirements for approval, but the agency can’t give it final approval because the branded drug’s patent protection hasn’t expired. The tentative approval was given under the President’s Emergency Plan for AIDS Relief, or PEPFAR, which aims to provide low-cost HIV medications to people in poor countries.

 

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URAC gives accreditation to PBM-owned specialty pharmacy

BY Alaric DeArment

LISLE, Ill. — Washington-based accrediting organization URAC has accredited pharmacy benefit manager Catamaran Corp.’s specialty pharmacy brand, Catamaran said.

The PBM said BriovaRx had been awarded URAC’s Specialty Pharmacy Accreditation. Catamaran said URAC offered the only third-party, voluntary accreditation program of this scope for the pharmacy benefit management and prescription services industry.

"BriovaRx’s robust offerings focus on the patient, ensuring one-on-one support and a personalized plan that addresses chronic conditions to help them lead healthy, vibrant lives," Catamaran chairman and CEO Mark Thierer said. "The URAC accreditation is a reflection of BriovaRx’s patient-centric approach that coordinates the efforts of providers, payers and manufacturers to keep treatments personalized and successful."

URAC president and CEO Alan Spielman said BriovaRx’s application for and receiving of accreditation demonstrated "a commitment to quality health care."

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