FDA Law Blog: Biosimilars

JUNE 27, 2023

James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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The Pharma Data

NOVEMBER 10, 2020

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. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The average annual growth in non-orphan pharmaceutical expenditure in the same period was only 3%. member states.

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Marketing Regulations Biosimilars Drugs 40

Agency IQ

AUGUST 2, 2024

and the E.C.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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The Pharma Data

JULY 8, 2021

is a leading global pharmaceutical company headquartered in Japan. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. is the largest dedicated food and drug law firm in the country. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Gibbs (Hall of Fame), John A.

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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.

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases.

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Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Worldwide’s Solutions to Addressing GLP-1 Treatment Challenges At Worldwide, we are actively leading initiatives to address the multifaceted challenges associated with GLP-1 treatments.

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.    The average cost of bringing a new drug to market is about $2.6 reported in 2021. trillion by 2028.

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Drug Target Review

MAY 5, 2025

While another pandemic has not reached our doorstep at least not yet our sense of urgency and creativity should be the fuel for reimagining clinical development processes. The staggering average cost of bringing a drug to market (more than $1 billion) is accompanied by a dismal success rate of justfive to seven percent.

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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.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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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. 4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 8] US Food and Drug Administration (FDA).

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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. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

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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. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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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., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

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The Pharma Data

OCTOBER 29, 2020

is a leading global pharmaceutical company headquartered in Japan. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube.

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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.

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

DECEMBER 9, 2020

is a leading global pharmaceutical company headquartered in Japan. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube.

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The Pharma Data

NOVEMBER 6, 2020

is a leading global pharmaceutical company headquartered in Japan. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube.

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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.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By geographical region, the global CRO services market in 2023 was dominated by North America. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., with full-year revenue of US$23.04

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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 (..)

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FDA Law Blog: Biosimilars

MARCH 13, 2024

is expressly authorized to rely upon the regulatory review activities by Pfizer Ireland Pharmaceuticals (Pfizer), the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. and OPKO Ireland Ltd. That segues us nicely into a bonus piece. Part 3½: Seriously?

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Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. There will also be a rescheduled webinar held at the end of the month to go over the Artificial Intelligence Airlock initiative spearheaded by the U.K.’s ’s Medicines and Healthcare products Regulatory Agency (MHRA).

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DrugBank

DECEMBER 4, 2024

   The Economics of Drug Access   The economics of drug access is a complex interplay of factors, including research and development (R&D) costs, manufacturing and distribution costs, intellectual property rights (IPR), pricing policies, and healthcare financing mechanisms.

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Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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Agency IQ

DECEMBER 1, 2023

The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Drug Target Review

APRIL 4, 2025

Co-founded and led by CEO Cameron Owen, rBio is a biotech company making a significant impact in the biosimilar insulin market. With a commitment to making insulin biosimilars more affordable and accessible, rBio is addressing a critical need for patients across the globe.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.

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