2018, Biosimilars, Licensing and Marketing

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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance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Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling.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

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals

Pharmaceuticals Pharmaceutical Companies Marketing Therapies

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. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

FDA

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. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” Reviews of orphan medicines and biosimilars have remained stable over the past three years.

Biosimilars

Biosimilars FDA Production Treatment

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

JANUARY 24, 2021

About Toripalimab Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. 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.

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. Read the AgencyIQ analysis here.

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. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future.

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.

Trials

Trials Production Clinical Trials Government

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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. In Europe, fourth-quarter Dupixent ® sales grew 76.9%

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

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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. In Europe, fourth-quarter Dupixent ® sales grew 76.9%

Vaccine

Vaccine Production FDA Pharmaceuticals

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 Recorded a $4.7

Production

Production International Clinical Trials Small Molecule

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

The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Europe, generic competition has started in certain countries after the expiration of Jevtana ® ’s market exclusivity in March 2021. In the U.S.,

Vaccine

Vaccine Production FDA FDA Approval

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. and four additional selling days in international markets. This guidance may be adjusted in the future as additional contracts are executed.

Vaccine

Vaccine Production FDA Clinical Trials

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

European Commission vs Big Pharma, or profit vs access?

Trends in Pharmaceutical Mergers and Acquisitions

FDA Action Alert: MacroGenics and Amgen

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

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

Sanofi delivered close to double-digit Q4 2020

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

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

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

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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