FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.

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FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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Agency IQ

JUNE 9, 2023

Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. The reduction from the current 10 years to either 9 or 5 years would allow earlier entry of generics and biosimilars. Generic and biosimilar developers benefit from earlier market entry.

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Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

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FDA Law Blog: Biosimilars

JULY 7, 2024

Labeling We note that while labeling requirements are not being phased in until stage 2 (May 6, 2026), the regulatory requirements in stage 1 appear to assume that at least some labeling requirements – such as UDI, which must be included in complaint files – will already be implemented).

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Drug Hunter

APRIL 24, 2023

A landmark part of the act is the requirement of Medicare to negotiate the prices for the 15 drugs with highest Medicare spend without generic and/or biosimilar substitutions across Part B (hospital drugs) and D (at-home drugs), with negotiated price implementation starting in 2026.

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FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. After this date, without action by Congress, FDA’s authority to grant rare pediatric disease designations would expire, and no vouchers could be granted unless previously granted such a designation.

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage.

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