Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. The Humira biosimilar market has arrived!

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Drug Patent Watch

FEBRUARY 3, 2021

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve….

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Drug Patent Watch

JUNE 17, 2024

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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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.

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Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. analyzes how marketplace dynamics of provider-administered biosimilars affect wholesalers’ gross margins. Section 4.4.

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Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!

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The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. Under this distribution and marketing agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co.,

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. Eylea ® is a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. Disclaimer.

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The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. billion across its major markets in 2020 alone. These major markets represented 75% of Teva’s revenues in 2020. Across 9 major markets in Europe, Teva saved healthcare systems $9.6 Teva saved the United States $28.8 billion in 2020, $4.2 jobs and contributed $15.7 billion in 2020.

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Drug Channels

JULY 11, 2022

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.

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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.

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Drug Channels

OCTOBER 23, 2023

A program driven by market dynamics and led by champions of channel strategy, join now to master the complexities of pharmacy and distribution models to accelerate market access –It's all happening December 11-13, 2023. Why should you attend this pivotal event? How is health policy affecting the distribution channel?

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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. provides a 10-year market exclusivity period. Orphan designation in the E.U. countries examined between 2010 and 2017. member states.

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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.

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. As always, we have updated all market and industry data with the most current information available.

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Drug Channels

JULY 23, 2024

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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The Pharma Data

APRIL 19, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. About Teva. Learn more at www.tevapharm.com.

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The Pharma Data

DECEMBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” Contact Information: Amphastar Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). percentage points (-3.6

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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. Yong-Jun Liu , the newly appointed President of Innovent also made his first public appearance on the virtual R&D day.

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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The Pharma Data

OCTOBER 27, 2020

Reddy’s”) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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FDA Law Blog: Biosimilars

JUNE 27, 2023

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. In addition to Mr.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

That clause excludes those ingredients that were first marketed as drug ingredients. Briefly, on October 11, 2022, FDA issued a letter in response to a new dietary ingredient notification (NDIN) by Inner Mongolia Kingdomway Pharmaceutical Ltd.

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The Pharma Data

MARCH 28, 2022

Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. About Ionis Pharmaceuticals, Inc. Biogen Inc.

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FDA Law Blog: Biosimilars

APRIL 4, 2023

In line with President Yoon’s orders for biohealth and digital healthcare development, the Ministry of Health and Welfare proposed new strategies with the following five core tasks to achieve the objectives of making new digital markets and activating biohealth exports.

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FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

It is attended by experienced professionals in the fields of regulatory, legal, public relations, marketing, and management who work in the pharmaceutical, medical device, diagnostic, biologics, and veterinary medicine industries.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Taiho Pharmaceutical Co., Taiho’s counsel quickly followed up with a letter to FDA and a supplemental submission to the PTO in February 2024 arguing otherwise: “[P]ermission for commercial marketing” was not effective under the September 30, 2022 FDA letter because the product would have been misbranded if marketed thereunder.

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The Pharma Data

MARCH 17, 2021

Robert Essner, Former chairman, CEO and president of Wyeth Pharmaceuticals, Inc. Shalini Sharp, Former CFO, Ultragenyx Pharmaceutical and Director Nominee. Organon will register its common stock under Section 12 of the Securities Exchange Act of 1934 (the “Exchange Act”). Cox, Former chairman and CEO of Humacyte, Inc.,

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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.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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