2018, Biosimilars and Licensing - 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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. See AgencyIQ’s full analysis of the 2018 framework, and industry response, here.]

FDA

FDA Biosimilars Production Regulations

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Read on for this week’s.

FDA

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

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

Biosimilars

Biosimilars Science FDA Licensing

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

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022. Based on the E.U.

Biosimilars

Biosimilars FDA Production Treatment

OPQ’s 2022 Report Shows the Global Task of Ensuring Quality

FDA Law Blog: Biosimilars

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. As one might expect, the lion’s share of the registered facilities—over 2,000 of the total—are located here in the U.S.

FDA

FDA Licensing Licensing Laboratories

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States.

FDA

FDA Clinical Trials Trials Treatment

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

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

FDA

FDA Biosimilars Science Production

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests.

FDA

FDA Laboratories Regulations Production

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2018; 9: 1595. 2018; 10 (1): 34–45. 2018; 3: 60-9. Tezepelumab was very well tolerated in patients with severe asthma.

Trials

Trials Production Clinical Trials Government

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2018; 9: 1595.

Trials

Trials Production Clinical Trials Government

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

Production

Production International Clinical Trials Small Molecule

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe.

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe.

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. In the U.S.,

Vaccine

Vaccine Production FDA FDA Approval

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA.

FDA

FDA Treatment FDA Approval 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. The FDA action converts the 2018 accelerated approval to full approval. 7) BNT162b2 has not been approved or licensed by the U.S.

Vaccine

Vaccine Production FDA Biosimilars

Drug Discovery Digest

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

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Trending Sources

FDA Action Alert: MacroGenics and Amgen

European Commission vs Big Pharma, or profit vs access?

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

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

OPQ’s 2022 Report Shows the Global Task of Ensuring Quality

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

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

A Final LDT Rule in April!? Will FDA be prepared?

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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