2026 and Biosimilars - Drug Discovery Digest

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors

FDA Law Blog: Biosimilars

MARCH 19, 2024

Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.

Regulations

Regulations FDA Drugs

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

FDA

FDA International Production Drugs

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

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.

Disease

Disease FDA FDA Approval Government

Inflation Reduction Act Faces More Legal Challenges, including long-expected PhRMA lawsuit

FDA Law Blog: Biosimilars

JUNE 26, 2023

September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.

Pharmaceuticals

Pharmaceuticals Drugs Research Government

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

Biosimilars

Biosimilars Science FDA Production

MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

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.

FDA

FDA Drugs Production

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

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.

FDA

FDA Science Regulations Biosimilars

Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases

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.”

Pharmaceuticals

Pharmaceuticals Drugs Government Regulations

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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).

Compliance

Compliance Laboratories FDA Regulations

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

Government

Government Marketing Production Drugs

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

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).

Production

Production FDA Clinical Trials Marketing

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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.

FDA

FDA Science Biosimilars Clinical Trials

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026.

FDA

FDA Regulations Packaging Compliance

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

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.

FDA

FDA Laboratories Regulations Compliance

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

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.

Marketing

Marketing Regulations Biosimilars Drugs

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

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.

Compliance

Compliance Drugs Pharmacy Licensing

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

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.

Small Molecule

Small Molecule Drugs Biosimilars Vaccine

Drug Discovery Digest

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors

Trending Sources

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

Inflation Reduction Act Faces More Legal Challenges, including long-expected PhRMA lawsuit

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

FDA Issues Long-Awaited QMSR Final Rule

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

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