By Meghan McCarthy, CQ Staff
Despite the lack of an established Food and Drug Administration approval pathway for follow-on biologics, biotech company Insmed says it intends to begin a clinical trial of its new follow-on biologic that is similar to Neupogen, a cancer drug produced by Amgen.
(Follow-on biologics are generic versions of complex biotech medicines. The biotech industry says that truly identical, generic versions of its drugs are impossible; generic manufacturers can only hope to produce similar products.)
Clinical Trial of Cancer Drug is a First
The announcement marks the first incidence of a U.S. company seeking approval for a Phase III trial of a follow-on biologic.
"Our strategy is to initiate this study, full well believing that the regulatory pathway will be established half way through or as we are completing the clinical studies," Insmed President and CEO Geoffrey Allan said. "We feel confident about all of this data because it demonstrates very clearly that the product has an identical bioequivalency profile to the innovator product . . . this gives us the confidence to go to the next level."
Bioequivalency is a common standard used by the FDA to approve generic drugs, and typically measures the rate of the generic drug absorption as compared to the brand name drug. Allan said his company's cancer biosimilar, INS-19, has demonstrated bioequivalency with the Amgen biologic.
Insmed plans to request a meeting with the FDA to discuss a Phase III clinical trial program for INS-19. Phase III studies are used to examine the effects of a drug on the general population, and the FDA has the power to place a hold on the study if they believe it is unsafe.
Indications from House and Senate lawmakers are that legislation to create an approval pathway is unlikely to move this year.
Two bipartisan bills have been introduced in the House legislating FDA approval pathways for follow-on biologic drugs. Rep. Anna G. Eshoo, D-Calif., introduced a measure that would allow for a period of data exclusivity of 14 years between innovator companies -- firms that are developing new biologic drugs -- and firms producing follow-on biologic drugs. Another bill sponsored by Rep. Henry A. Waxman, D-Calif., has no period of data exclusivity, providing an abbreviated pathway for the approval of follow-on biologic drugs.
The Senate Health, Education, Labor and Pensions Committee has approved legislation that would authorize the FDA to approve generic versions of biotech drugs after a 12-year exclusivity period for the original drug maker.
While Insmed's announcement is unlikely to have an impact on legislation in the 110th Congress, Allan said the change in the dialogue surrounding follow-on biologics has given him hope for the coming years.
"When I first started to talk in front of Congress, some of the major themes the bio lobby was arguing was that the science wasn't available to develop these drugs, and this data demonstrates we are very well equipped scientifically to develop follow-on biologics . . . and continues to reinforce that the science is not an issue."
"Our strategy is to initiate this study, full well believing that the regulatory pathway will be established half way through or as we are completing the clinical studies," Insmed President and CEO Geoffrey Allan said. "We feel confident about all of this data because it demonstrates very clearly that the product has an identical bioequivalency profile to the innovator product . . . this gives us the confidence to go to the next level."
Bioequivalency is a common standard used by the FDA to approve generic drugs, and typically measures the rate of the generic drug absorption as compared to the brand name drug. Allan said his company's cancer biosimilar, INS-19, has demonstrated bioequivalency with the Amgen biologic.
Insmed plans to request a meeting with the FDA to discuss a Phase III clinical trial program for INS-19. Phase III studies are used to examine the effects of a drug on the general population, and the FDA has the power to place a hold on the study if they believe it is unsafe.
Indications from House and Senate lawmakers are that legislation to create an approval pathway is unlikely to move this year.
Two bipartisan bills have been introduced in the House legislating FDA approval pathways for follow-on biologic drugs. Rep. Anna G. Eshoo, D-Calif., introduced a measure that would allow for a period of data exclusivity of 14 years between innovator companies -- firms that are developing new biologic drugs -- and firms producing follow-on biologic drugs. Another bill sponsored by Rep. Henry A. Waxman, D-Calif., has no period of data exclusivity, providing an abbreviated pathway for the approval of follow-on biologic drugs.
The Senate Health, Education, Labor and Pensions Committee has approved legislation that would authorize the FDA to approve generic versions of biotech drugs after a 12-year exclusivity period for the original drug maker.
While Insmed's announcement is unlikely to have an impact on legislation in the 110th Congress, Allan said the change in the dialogue surrounding follow-on biologics has given him hope for the coming years.
"When I first started to talk in front of Congress, some of the major themes the bio lobby was arguing was that the science wasn't available to develop these drugs, and this data demonstrates we are very well equipped scientifically to develop follow-on biologics . . . and continues to reinforce that the science is not an issue."
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