FDA URGED TO REVEAL BIOSIMILAR NAMING GUIDELINES
by Ed Silverman
One week after the FDA received its first request to approve a biosimilar medicine, a handful of U.S. senators has asked the U.S. Department of Health and Human services when a formal policy will be adopted for naming these medications.
Their missive was sent just as the World Health Organization suggested a new proposal for naming biosimilars, which are designed to emulate brand-name biologics and are forecast to save billions of dollars in health care costs.
At issue is whether biosimilars should be given the same International Non-Proprietary Name, or INN, as brand-name biologics. The WHO oversees the global INN system, but individual regulatory agencies in each country are not bound by the latest WHO proposal.
As we have noted previously, the naming debate is particularly contentious and has divided the pharmaceutical industry, which has been lobbying the FDA to chart a course. A central focus of the debate is whether different INNs would hamper substitution needed for lowering health care costs.
Brand-name drug makers and biotechs want biosimlars to have unique or generic names to distinguish the medicines from the original biologics. They argue that different names would make it easier to track adverse events.
Generic drug makers believe a new naming standard may confuse health care providers as they sort out whether the medicines are really the same and attempt to verify dosing and regiments. And they maintain side effects can be traced through national drug codes and lot numbers.
They also argue that brand-name drug makers and biotechs are maneuvering to blunt competition before biosimilars are widely used in the U.S. Drug makers from on both sides of the debate have petitioned the FDA to adopt their respective positions.
For its part, the FDA has remained silent on its plans, although in their letter, five Republican members of the U.S. Senate Committee on Health, Education, Labor & Pensions, wrote that they believe the FDA has sent its naming guidance to the HHS for approval.
An FDA spokeswoman would only say that the agency is “currently considering the appropriate naming convention. We will take into consideration all comments we’ve received as we move forward in developing future policies, including naming.”
We asked the HHS for comment and will update you with any reply.
The senators are concerned the FDA has already begun the process of reviewing biosimilar applications and holding talks with drug makers before allowing its planned guidance to be vetted publicly. Typically, an FDA draft guidance is disclosed and comment can be made before anything is finalized.
Two weeks ago, the Sandoz unit of Novartis that sells generic medicines, sought FDA approval to sell a biosimilar version of Neupogen, an Amgen medication that is used to reduce the risk of infection in cancer patients under chemotherapy. This is believed to be the first such application to the FDA.
This is not the first time that FDA policy toward biosimilar naming has drawn attention from members of the Senate. Last fall, the agency had removed a policy from its web site that discussed biosimilar naming and the senators believed this signaled an unpublicized shift by FDA officials.
At the time, the six U.S. senators – which included five Democrats and one Republican – argued against any requirement that biosimilars carry unique INNs that would distinguish them from the brand-name biologics. The most recent letter did not articulate a position.
Their missive was sent just as the World Health Organization suggested a new proposal for naming biosimilars, which are designed to emulate brand-name biologics and are forecast to save billions of dollars in health care costs.
At issue is whether biosimilars should be given the same International Non-Proprietary Name, or INN, as brand-name biologics. The WHO oversees the global INN system, but individual regulatory agencies in each country are not bound by the latest WHO proposal.
As we have noted previously, the naming debate is particularly contentious and has divided the pharmaceutical industry, which has been lobbying the FDA to chart a course. A central focus of the debate is whether different INNs would hamper substitution needed for lowering health care costs.
Brand-name drug makers and biotechs want biosimlars to have unique or generic names to distinguish the medicines from the original biologics. They argue that different names would make it easier to track adverse events.
Generic drug makers believe a new naming standard may confuse health care providers as they sort out whether the medicines are really the same and attempt to verify dosing and regiments. And they maintain side effects can be traced through national drug codes and lot numbers.
They also argue that brand-name drug makers and biotechs are maneuvering to blunt competition before biosimilars are widely used in the U.S. Drug makers from on both sides of the debate have petitioned the FDA to adopt their respective positions.
For its part, the FDA has remained silent on its plans, although in their letter, five Republican members of the U.S. Senate Committee on Health, Education, Labor & Pensions, wrote that they believe the FDA has sent its naming guidance to the HHS for approval.
An FDA spokeswoman would only say that the agency is “currently considering the appropriate naming convention. We will take into consideration all comments we’ve received as we move forward in developing future policies, including naming.”
We asked the HHS for comment and will update you with any reply.
The senators are concerned the FDA has already begun the process of reviewing biosimilar applications and holding talks with drug makers before allowing its planned guidance to be vetted publicly. Typically, an FDA draft guidance is disclosed and comment can be made before anything is finalized.
Two weeks ago, the Sandoz unit of Novartis that sells generic medicines, sought FDA approval to sell a biosimilar version of Neupogen, an Amgen medication that is used to reduce the risk of infection in cancer patients under chemotherapy. This is believed to be the first such application to the FDA.
This is not the first time that FDA policy toward biosimilar naming has drawn attention from members of the Senate. Last fall, the agency had removed a policy from its web site that discussed biosimilar naming and the senators believed this signaled an unpublicized shift by FDA officials.
At the time, the six U.S. senators – which included five Democrats and one Republican – argued against any requirement that biosimilars carry unique INNs that would distinguish them from the brand-name biologics. The most recent letter did not articulate a position.
Fuente: BIO SmartBrief - THE WALL STREET JOURNAL
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