FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. to maintain its gold standard of pharmaceutical quality. By Kalie E.

Pharmaceuticals 59

Pharmaceuticals FDA Production Licensing 59

Drug Discovery World

MARCH 29, 2023

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. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

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 52

FDA Biosimilars Clinical Trials Licensing 52

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

FDA 59

FDA Drugs Licensing Licensing 59

The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” The Swiss Agency for Therapeutic Products (Swissmedic) has demanded that license holders check suppliers more rigorously when importing finished medicinal products from outside the European Union. . EMA Report. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Biosimilars 52

The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. is a leading global pharmaceutical company headquartered in Japan.

Marketing 40

Marketing Disease Clinical Trials Treatment 40

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 40

Biosimilars Science FDA Licensing 40

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 40

Biosimilars FDA Production Treatment 40

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

FDA 59

FDA Production Marketing Pharmacy 59

FDA Law Blog: Biosimilars

MARCH 13, 2024

After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. That was the case in the PTO’s April 3, 1995 decision denying a PTE as to U.S. Lehman , No.

FDA 59

FDA FDA Approval Production Marketing 59

Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

SEPTEMBER 22, 2023

patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS. Similarly, the agency simply notes that it would review potential biosimilar or interchangeable products consistent with its existing regulatory expectations for licensure.

FDA 40

FDA Biosimilars Production Regulations 40

The Pharma Data

JANUARY 24, 2021

About Toripalimab Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States.

FDA 52

FDA Clinical Trials Trials Treatment 52

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

JULY 8, 2024

and the E.C.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease 40

Disease FDA Clinical Trials Licensing 40

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 52

Biosimilars Production Treatment FDA 52

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

FDA 40

FDA Science Regulations Clinical Trials 40

The Pharma Data

DECEMBER 9, 2020

Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Michel Vounatsos, Chief Executive Officer at Biogen. is a leading global pharmaceutical company headquartered in Japan.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. TEL AVIV, Israel & ZURICH–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. Teva and Bioeq will share revenue from the commercialization of the biosimilar.

Biosimilars 52

Biosimilars International Licensing Licensing 52

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

Production 52

Production Marketing Research Government 52

Agency IQ

FEBRUARY 12, 2024

This is a topic that seems highly related to a recent report from the Reagan-Udall Foundation for the FDA focused on “enhancing post-market evidence generation for medical products” that calls for a “learning health care system.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Nick Pittman, Marketing Manager, Global Biopharmaceutical Business, Waters Corporation, on: ‘Robust multi-level LC-MS workflows for biosimilar comparability assessment’.

Engineering 130

Engineering Therapies Protein Production Science 130

The Pharma Data

OCTOBER 29, 2020

Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. 29, 2020– Alexion Pharmaceuticals, Inc. Germany & Japan. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

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. Priority A List. Priority B List.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 8, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Specialty Care.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Specialty Care.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

Agency IQ

DECEMBER 1, 2023

The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Vaccines delivered growth in its core segments. to €2,638 million.

Vaccine 52

Vaccine Production FDA FDA Approval 52

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 40

Vaccine Production FDA Biosimilars 40

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. pharmaceutical law ceased to apply to the U.K. from the E.U.

International 40

International Regulations Production Marketing 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

FDA 40

FDA Science Biosimilars Regulations 40