2027 and Biosimilars - Drug Discovery Digest

Article FDA Thank You New FDA guidance on interchangeable biosimilar labeling heads to White House for review

Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

Biosimilars

Biosimilars FDA Production Licensing

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. The certificate extends the term of U.S.

Clinical Trials

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science

Science Biosimilars FDA Production

Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog: Biosimilars

JUNE 8, 2023

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

FDA

FDA Biosimilars Production Government

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

FDA

FDA International Production Drugs

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in negotiations preceding user fee reauthorization in 2027 (taking effect in FY2028, which begins on October 1, 2027).

Laboratories

Laboratories FDA Regulations Production

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. We, and many stakeholders, agree that RWD and RWE can play an invaluable role.

FDA

FDA Production Trials Pharmacy

FDA Proposes to Ban Brominated Vegetable Oil in Food

FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

Moreover, California recently enacted the California Food Safety Act , prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as of January 1, 2027. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

FDA

FDA Production Regulations

“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

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

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.”

Production

Production Clinical Trials FDA Drugs

An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards).

Government

Government Compliance Drugs Production

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027.

FDA

FDA Regulations Clinical Trials Production

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

FDA Law Blog: Biosimilars

MARCH 5, 2024

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Because the alleged harm arises from the Act, not from the Guidance, the court found that AstraZeneca did not meet the causation or redressability elements of standing under this argument.

Government

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

Regulations

Regulations Clinical Trials Production Trials

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

FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

FDA

FDA Regulations Production Drugs

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. RE47,739 for Ibrance by more than four years until March 2027. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

Vaccine

Vaccine Production FDA Clinical Trials

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

That would leave 19% of staff affected by furloughs.

FDA

FDA Science Biosimilars Regulations

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027.

Regulations

Regulations Production FDA Approval Drugs

Drug Discovery Digest

Article FDA Thank You New FDA guidance on interchangeable biosimilar labeling heads to White House for review

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

Trending Sources

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Update on CDER, CBER, and CDRH Meetings with Industry

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

Proposed LDT Rule Raises Many Questions but Provides Few Answers

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Proposes to Ban Brominated Vegetable Oil in Food

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

MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

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

Article EMA Thank You What we expect European regulators to do in August and September 2024

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

FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

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