2022, Biosimilars and Packaging - Drug Discovery Digest

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

Biosimilars

Biosimilars FDA Production Packaging

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development. billion.

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. for the years 2020 to 2022.

Biosimilars

Biosimilars FDA Production Treatment

eMDR System Enhancements

FDA Law Blog: Biosimilars

MARCH 8, 2023

Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023. This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.

Packaging

Packaging FDA Regulations Production

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

Treatment

Treatment Clinical Pharmacology Drugs Biosimilars

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

FDA

FDA Packaging Laboratories Engineering

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). According to a FY 2022 report , the program had $13.1 The longest shutdown in U.S.

Government

Government FDA Biosimilars Regulations

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Biosimilars

Biosimilars Production Treatment FDA

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA

FDA Biosimilars Science Production

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

FDA

FDA Regulations Packaging Compliance

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

FDA FDA Approval Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

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

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

FDA

FDA Science Biosimilars Regulations

Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would Require

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

Regulations

Regulations Production Packaging Licensing

Drug Discovery Digest

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

Trending Sources

European Commission vs Big Pharma, or profit vs access?

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

eMDR System Enhancements

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Amgen Reports Second Quarter 2021 Financial Results

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

FDA Issues Long-Awaited QMSR Final Rule

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would Require

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