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During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state. As you will see below, CVS Healths formulary actions led to rapid uptake of a low-list-price biosimilar.
On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). Stay up to date on biosimilar news, applications and approvals in China by following our Big Molecule Watch China blog.
Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency (EMA) panel recommended approval of its copycat biologic. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.
Leading FDAs policy implementation of the MODERN Labeling Act , the statutory authority allowing FDA to make certain generic drug labeling updates. Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA. But thats all in the past now.
ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM Discusses Biosimilar Interchangeability and Substitution at Oregon’s St. View the resource guide here.
This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Click here to see the original post from September 2023. Here’s the press release: CVS Health Launches Cordavis.
Benjamin reviews the growing trend of PBMs vertically integrating into the production of biosimilars. The findings shed light on payers' view of biosimilar conpetition, contracting challenges, and other issues. Click here to learn more about MMIT’s Custom Market Research offering for biosimilar manufacturers.
Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.
ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.
RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Indeed, FDA states, the existence of a certification program alone would not relieve manufacturers from their responsibilities to ensure that their labeling and distribution practices for RUO/IUO products are consistent with the products RUO/IUO label.
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.
The Humira biosimilar market just took another step forward—but remains far from its ideal state. Last week, Cigna’s Express Scripts announced that it that will follow CVS Health’s CVS Caremark business and remove Humira from its largest commercial formulary in favor of multiple biosimilars. All rights reserved.
prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”
The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.
As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s
This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.
In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. The post Biosimilars Webinar Series appeared first on Big Molecule Watch.
Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.
DEA published a Notice of Proposed Rulemaking (NPRM), signed by Attorney General Merrick Garland, proposing to reschedule marijuana in May 2024 that elicited over 43,500 comments. 44,597, 44,621 (May 21, 2024). In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled.
to take photographs as necessary; to collect samples; talk to pertinent staff ; or to collect food labels and labeling). But a recent Warning Letter raises new questions for regulated companies on whether FDA can interview company employees, and if so, how companies should handle these requests during an inspection.
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s
We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here. Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025.
Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. 105288 (Dec.
By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.
In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.
In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2 Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. million over the next four years.
The draft guidance (June 2024) defines an EDDO as the “design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site. Comments may be submitted by September 30, 2024. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.
Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable.
On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Director Deborah L.
In January 2024, FDA affirmed to the PTO in a letter that “NDA 214801 was approved on September 30, 2022, which makes the submission of the patent term extension application on November 29, 2022, not timely within the meaning of 35 U.S.C. It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. billion prescriptions dispensed by U.S. pharmacies in 2023, demonstrating this horizontal consolidation.
Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).
on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. August 2024 Untitled Letter to Mirati Therapeutics Inc.
If a company receives a voucher, it must meet certain requirements to qualify for expedited review: an applicant must submit the CMC portion of its application and draft labeling at least 60 days prior to the final application submission and be available for “ongoing communication with prompt responses to FDA inquiries.”
As an example, we filed a 513(g) request in December 2024. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.
Users of eSTAR templates need to add attachments for cybersecurity risk management, cybersecurity management plan, continuing support plan, and cybersecurity labeling. implant programming), (4) software bill of materials, and (5) general labeling (connectivity and associated general cybersecurity risks, updateability/process).
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.
With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. Negotiations will take place over the course of the following year, ending on August 1, 2024. The MFP will then be published on September 1, 2024, and will take effect on January 1, 2026.
The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food.
FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. On February 23, 2024, Dr. Marks issued his final decision , which concluded that the grounds for withdrawing approval were met. Tobolowsky & Michelle L. The docket also contains a brief summary of the meeting.
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.
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