FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. The Court thus explained that interpreting the patent in 35 U.S.C.

Pharmaceutical Companies

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

FDA Law Blog: Biosimilars

JULY 23, 2025

Food and Drug Administration (FDA). In that role, he led and supported the agency’s litigation efforts in high-stakes matters involving drug approvals, exclusivity disputes, enforcement actions, and administrative law challenges. He also provides strategic litigation support and proactive counsel on agency engagement.

Government

FDA Law Blog: Biosimilars

APRIL 7, 2025

Indeed, most Center for Veterinary Medicine (CVM) Warning Letters arise because products advertised are actually new animal drugs. But this year, CVM has issued two notable warning letters and one Untitled Letter concerning the promotion of animal drugs that caught our attention because of the level of detail and specificity included.

Vaccine

Drug Patent Watch

MARCH 19, 2025

Unlocking Strategic Investment Opportunities in the Pharmaceutical Industry As we navigate the ever-evolving landscape of the pharmaceutical industry, one thing remains constant: the expiration of patents on blockbuster medications. This has led to a significant increase in investment in the generic and biosimilar sectors.

Biosimilars

Drug Target Review

MAY 5, 2025

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. Taking big risks with little reward Current drug development frameworks are burdened with inefficiencies and high failure rates.

Clinical Development

Drug Patent Watch

APRIL 8, 2025

"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Evaluate revenue growth, profitability, and cash flow.

Pharma Companies

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?

Drugs

The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

Pharmaceutical Companies

Drug Patent Watch

APRIL 1, 2025

The Biosimilar Revolution: How Europe's Generic Drug Industry is Evolving As we navigate the ever-changing landscape of the pharmaceutical industry, one trend is clear: biosimilars are here to stay. However, the introduction of biosimilars has introduced a new layer of complexity.

Biosimilars

FDA Law Blog: Biosimilars

APRIL 7, 2025

Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institutes 23rd Advanced Summit on Life Sciences Patents , which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY.

Science

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA). He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). Kennedy does not say what the alternative to user fees would be given current budget realities.

FDA

FDA Law Blog: Biosimilars

MAY 27, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. This tour to engage with pharmaceutical and biotech CEOs is unprecedented. Interestingly, leadership from the Center for Drugs is absent and the tour excludes CEOs in the device space.

FDA

FDA Law Blog: Biosimilars

JUNE 1, 2025

Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. stating that he would advise President Trump to ban pharmaceutical advertising on TV. Department of Health and Human Services Secretary, Robert F.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

JULY 13, 2025

What This Means for Industry For FDA-regulated sectors—including pharmaceuticals, medical devices, food safety, and cosmetics—this convergence of executive and judicial action could have immediate and longer-term consequences such as regulatory delays or disruptions.

FDA

FDA Law Blog: Biosimilars

JUNE 26, 2025

Karst — Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced ( here and here ) the release of a report, titled “ Assessment of the Impact of Settlements ,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and biosimilar biological products.

Biosimilars

FDA Law Blog: Biosimilars

MAY 15, 2025

Gaulkins presentation, Product Price Increases: A SPTR Practical Walkthrough , will provide an interactive case study outlining the hypothetical enforcement, appeal, and settlement scenarios that may apply to qualifying drug price increases.

Science

Drug Patent Watch

MARCH 31, 2025

The Future of Healthcare: Unpacking the Global Generic Drug Market As we navigate the ever-changing landscape of the pharmaceutical industry, one thing is clear: the demand for affordable, high-quality medications is on the rise. What do you think is the most significant challenge facing the global generic drug market?

Marketing

FDA Law Blog: Biosimilars

MARCH 12, 2025

Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S. PTOs PTAB, the FTC, and the FDA, to tackle the critical legal, regulatory, and business issues shaping pharmaceutical patent litigation.

FDA

Drug Patent Watch

OCTOBER 16, 2024

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

Biosimilars

Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Net prices in therapeutic classes with biosimilar competition have declined by 60% or more over the past few years. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. drug distribution.

Biosimilars

Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

Biosimilars

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

DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

Biosimilars

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. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived!

Biosimilars

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

FDA

Drug Channels

OCTOBER 27, 2021

So grab your pillow case and stuff it with treats from the great Drug Channels pumpkin patch: Spooky! PBMs are conjuring a terrifying number of formulary exclusions for oncology drugs Eerie! It’s the biosimilar boom! d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

Biosimilars

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

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. Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S.

Pharmaceuticals

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

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.

Biosimilars

Drug Patent Watch

MAY 15, 2025

"Unlocking the Secrets of the FDA's Orange and Purple Books: Insider Tips from a Drug Patent Research Expert As the pharmaceutical industry continues to evolve at breakneck speed, staying ahead of the curve requires more than just a keen eye for innovation it demands a deep understanding of the regulatory landscape.

FDA

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. Biosimilars marketed in the U.S. for the treatment of diabetes.

Biosimilars

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

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

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. Food and Drug Administration (FDA) and three that are approved in the EU.

Biosimilars

Drug Channels

JULY 11, 2022

Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *. Drug Channels, or any of its employees. d/b/a Drug Channels Institute. Delivered as a Hybrid Event. O’Brien, Pharm.

Specialty Pharmacies