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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.
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.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.
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 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.
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!
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.
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. trillion by 2028.
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.
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.
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.
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.
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.
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.,
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.
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.
1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, In Britain, 2.88
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.
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.
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. II, § 2, cl.
Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. MacroGenics partnered with Zai Labs, based in Shanghai, China and San Francisco, on the drug.
(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.
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. d/b/a Drug Channels Institute.
I am pleased to announce our new 2023–24 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.
It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. These data remain inconvenient for drug pricing flat earthers (#DPFE): When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023. See the second chart below.
On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.
Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. In other words, it’s a sweeping application across the industry.
Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. It’s these varied scenarios that give quality managers nightmares.
ENVI also called on the European Commission to talk to Member States about new pricing criteria such as whether a drug is “Made in Europe.”. . Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.”
FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. As a reminder, the U.S.
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of PharmaceuticalDrugs and Other Controlled Substance Violations, Nov. Providers should be aware of the other drugs prescribed to their patients. 6, 2023 ( DOJ Press Release ).
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
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 .
Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. After his remarks, Mr.
Teva Pharmaceutical Industries Ltd. As one of the largest manufacturers of affordable generic medicines, Teva saves patients and payers around the globe billions of dollars each year in lower prescription-drug costs,” said Alex Brill, CEO of MGA. Teva saved the United States $28.8 billion in 2020, $4.2 As the U.S.
But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments. He originated the idea of patent certifications, new drug exclusivity, and the Bolar exemption. (And
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). Those efforts add up to a clear message to industry that FDA is looking beyond CGMP when it evaluates drug makers. The new parts of OPQ reflect that.
Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. In all of these letters, CVM alleges that the distributors who “take orders” are selling unapproved drug products—typically for infection control—for use in fish and, in some cases birds.
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. 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.
Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.
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