FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

Production 52

Production Clinical Trials FDA Drugs 52

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Author Information William E. Spanogle, Ph.D.

FDA 52

FDA FDA Approval Biosimilars Regulations 52

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

This includes both forging the application of the FDAMA 115 “single study plus confirmatory evidence” standard as well as expanding the use of accelerated approval for products in conditions outside of cancer. We are proud as a firm of this honor and would also like to extend congratulations to all of this year’s Law360 Rising Stars!

Science 81

Science FDA Approval FDA Drug Development 81

DrugBank

OCTOBER 4, 2024

These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.

Pharmaceuticals 81

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

Clinical Trials 59

Clinical Trials Production Trials Drugs 59

Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. The hybrid format was necessary due to limitations in the number of attendees who could be accommodated in-person in the handful of newly revamped meeting rooms.

FDA 59

FDA Biosimilars Production Drug Development 59

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Beitz for 14 years was Director of the Office of Drug Evaluation III (ODE 3) in OND where she oversaw the Division of Gastroenterology and Inborn Errors of Metabolism, the Division of Dermatology and Dental Products, and the Division of Bone, Reproductive and Urology Products.

FDA 49

FDA Drugs Drug Development Doctors 49

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. billion in 2023 attributable to its laboratory products and biopharma services segment (53.8%

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

The Pharma Data

SEPTEMBER 17, 2020

Through this collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the world should one or more of Lilly ‘s antibody therapies prove successful in clinical testing and receive regulatory approval. government, we could become subject to significant sanctions.

Therapies 52

Therapies Production Government Disease 52

Agency IQ

JUNE 9, 2023

The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). Unmet medical need requires the disease to remain associated with high morbidity or mortality if a product is approved for that condition.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

AUGUST 2, 2024

Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

Agency IQ

JUNE 29, 2023

264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. If you make a tissue product you may produce one lot per patient where a gene therapy may only need a handful of lots through Phase 3.

Therapies 52

Therapies FDA Clinical Development Production 52

Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

The proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. ’s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Conversations in Drug Development Trends

JULY 9, 2024

The demand for these medications, which play a vital role in managing diabetes and obesity, has far outpaced production capabilities, leading to widespread scarcity.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

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. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.

FDA 40

FDA Clinical Trials Trials Treatment 40

The Pharma Data

OCTOBER 29, 2020

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Disease 40

Disease Marketing Clinical Trials Treatment 40

The Pharma Data

DECEMBER 9, 2020

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

NOVEMBER 6, 2020

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Disease 40

Disease FDA Clinical Trials Licensing 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.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. We heard and felt the anxiety from many of our clients about the uncertainty this caused. After all, this is what incentives are for.

Disease 64

Disease FDA FDA Approval Government 64

The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

Therapies 40

Therapies Virus Treatment Clinical Trials 40

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

Biosimilars 52

Biosimilars International Licensing Licensing 52

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Synthroid® oral tablets) were marketed as unapproved drugs for the treatment of hypothyroidism in the US.

FDA 52

FDA Animal Testing Pharmacokinetics Small Molecule 52

Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

FDA 59

FDA FDA Approval Production Marketing 59