The Pharma Data

MARCH 22, 2023

As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, President, Sandoz Inc., Head of North America. “As

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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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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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BioPharma Drive: Drug Pricing

APRIL 5, 2024

The German pharmaceutical company is “streamlining” its custom-facing teams behind Cyltezo, a copycat version of AbbVie’s immune disease drug Humira.

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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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Drug Channels

OCTOBER 27, 2021

It’s the biosimilar boom! Recent posts have covered: Walgreens’ new direction; controversary over independent pharmacy counting; insurer consolidation; retail pharmacy M&A; drug pricing policy; Prime Therapeutics; 340B contract pharmacy litigation; pharmaceutical antitrust; oncology care model; and Peter Bach’s nuptials.

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The Pharma Data

APRIL 18, 2022

. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved by the U.S. Reese, M.D., executive vice president of Research and Development at Amgen.

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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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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. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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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 Discovery World

DECEMBER 21, 2023

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, commented: “Barriers to US market growth will primarily result from the loss of patent exclusivity of current biologics, and the subsequent entry of biosimilars to these reference therapies.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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Drug Channels

SEPTEMBER 17, 2024

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S.

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Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. we analyze the IRA’s likely consequences for wholesalers and the overall pharmaceutical business. and Section 6.4.3.

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Drug Discovery World

FEBRUARY 22, 2024

Out of the top 20 players, nine companies indicated positive growth in stock market value, with four companies – Lilly (59.2%), Novo Nordisk (51.5%), Vertex Pharmaceuticals (41.4%) and Regeneron Pharmaceuticals (21.8%) – reporting more than 20% YoY growth in market capitalisation.

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Drug Discovery World

AUGUST 22, 2022

He began his career as a user of lab automation at a major pharmaceutical company before moving to work for a leading manufacturer of laboratory automation as an applications scientist. How can automation push the development of biologics and biosimilars? . Adam Prosho, Global ILS Training Director, CBRE.

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Drug Discovery World

MAY 1, 2023

DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years.

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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. This report—our fourteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S.

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The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

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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. See the second chart below.

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The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

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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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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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FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

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The Pharma Data

DECEMBER 13, 2020

Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The drug is an anti-CD20 antibody.

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The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” ENVI also urged the Commission to develop appropriate regulatory frameworks for advanced therapy medicinal products and to work with EMA “to consider extending the application of rolling reviews to other emergency medicines.”

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Drug Discovery World

MARCH 29, 2023

He pointed out that Europe was the first region to approve biosimilars. 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. He said: “The products that are authorised in EU are largely the same as other regions. You can compare timelines.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. Similarly, biosimilars are expected to grow. Regulatory .

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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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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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The Pharma Data

MAY 4, 2021

The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March. . Posted 04 May 2021 | By Michael Mezher .

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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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FDA Law Blog: Biosimilars

NOVEMBER 20, 2023

Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). By John W.M. It is the latest item on a long list of similar initiatives that have marked 2023.

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Drug Channels

JULY 29, 2020

My recent tweets have highlighted: VC’s pharmacy love, physicians’ biosimilar concerns, drug trend in workers’ comp, copay accumulator news, the outlook for insurance costs, remdesivir pricing, Philly pharmacies, how paid parking boosts telemedicine, and more.

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The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. biosimilars market continues to develop, savings are expected to grow and surpass $100 billion from 2020 to 2024. Teva saved the United States $28.8 billion in 2020, $4.2 billion of which were direct savings to US patients Teva delivered $9.6 As the U.S.

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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. Spanogle, Ph.D.

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