US FDA rejects Amgen bid to force biosims firms to share info before review

By Gareth Macdonald contact

- Last updated on GMT

US FDA rejects Amgen Citizen Petition
US FDA rejects Amgen Citizen Petition
Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.

The agency denied​ Amgen’s Citizen Petition​ this week, arguing that: “Neither section 351(k) nor section 351(1) requires FDA to impose a certification requirement as part of the biosimilar review process​.”

The FDA contrasted this with section 505(b) of the FD&C Act, which requires small molecule innovators to identify patents for inclusion in the orange book.

The law also requires that generics firms certify that any patents relating to the copycat drug they are filing are listed in the orange book.

The agency also said: “The BPCI​ Act generally does not describe any FDA involvement in monitoring or enforcing the information exchange by creating a certification process or otherwise​” beyond the requirement that it publishes patent cases against biosimilar firms in the Federal Register.

US Court backs Sandoz

The FDA’s decision is the second legal disappointment Amgen has faced in as many weeks. On March 20, a California District Judge rejected the Big Biopharmaceutical firm’s effort to stop Sandoz launching Zarxio (filgrastim-sndz), a biosimilar version of its white blood cell booster Neupogen.

Judge Richard Seebord said​ with as Neupogen’s patent had already expired there was “no basis on which Amgen is entitled to injunctive relief or other remedies for disadvantages it may suffer due to market competition from Sandoz​.”

Amgen’s complaint​ was that Sandoz did not provide it with details of the Zarxio manufacturing process and application.

Seeboard said: “The BPCIA renders permissible a subsection (k) applicant’s decision not to provide its BLA and or manufacturing information to the reference product sponsor, subject only to the consequences set forth in 42 U.S.C. § 262(l)(9)(C).​”

He added that: “Such a decision alone does not offer a basis for the sponsor to obtain injunctive relief, restitution, or damages against the applicant.​"

Amgen has appealed the decision.

Related topics: Regulatory & Safety, Regulations

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