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.

Biosimilars 110

Biosimilars Pharmaceuticals Marketing 110

Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

Biosimilars 52

Biosimilars Marketing Treatment Small Molecule 52

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.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

Pharmaceuticals 76

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 76

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.

Biosimilars 68

Biosimilars Hospitals Independent Pharmacies Pharmacy 68

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.

Biosimilars 52

Biosimilars Pharmacokinetics FDA Approval Packaging 52

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.

Biosimilars 52

Biosimilars Production FDA Approval FDA 52

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.

Pharmaceuticals 80

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 80

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.

Pharmaceuticals 71

Pharmaceuticals Biosimilars Licensing Licensing 71

Drug Patent Watch

DECEMBER 8, 2024

The pharmaceutical industry is heavily reliant on patents to protect intellectual property and maintain market exclusivity. However, with the increasing competition from generic and biosimilar manufacturers, patent invalidity claims have become a significant challenge for pharmaceutical companies.

Biosimilars 98

Biosimilars Pharmaceutical Companies Drugs Pharmaceuticals 98

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. is an attempt on international collaboration of biosimilar medicines. and Alvotech & CCHT Biopharmaceutical Co.,

Biosimilars 40

Biosimilars Pharmaceuticals Pharmaceutical Companies Marketing 40

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.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.

Biosimilars 76

Biosimilars Production FDA Pharmaceuticals 76

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!

Pharmaceuticals 66

Pharmaceuticals Biosimilars Licensing Licensing 66

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.

Biosimilars 62

Biosimilars Pharmaceutical Companies Pharmaceuticals Disease 62

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.

Biosimilars 52

Biosimilars Disease Licensing Licensing 52

Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics.

Licensing 96

Licensing Licensing Drugs Biosimilars 96

Drug Channels

OCTOBER 1, 2024

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus.

Biosimilars 40

Biosimilars Pharmacy Production FDA 40

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.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

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.

Biosimilars 59

Biosimilars FDA Production Marketing 59

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 Production 40

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.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

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.

Specialty Pharmacies 94

Specialty Pharmacies Pharmacy Biosimilars Compliance 94

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.

Biosimilars 52

Biosimilars Treatment Government Hospitals 52

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.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

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.

Government 59

Government FDA Pharmaceuticals FDA Approval 59

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.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

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.”

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

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.

Pharmaceuticals 40

Pharmaceuticals Pharmacy Biosimilars Licensing 40

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.

Pharmaceuticals 52

Pharmaceuticals Licensing Licensing Drugs 52

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 .

Science 52

Science Biosimilars FDA Production 52

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.

Biosimilars 52

Biosimilars Pharmaceuticals Production Drugs 52

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.

Pharmaceuticals 59

Pharmaceuticals Licensing Licensing Compliance 59

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.

Pharmacy 52

Pharmacy Biosimilars Drugs Pharmaceuticals 52

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.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Compliance Biosimilars Pharmaceuticals 52

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.

Marketing 52

Marketing Biosimilars Pharmaceuticals 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. Spanogle, Ph.D.

FDA 52

FDA FDA Approval Biosimilars Regulations 52