Drug Channels

SEPTEMBER 4, 2024

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.

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Big Molecule Watch

MAY 3, 2024

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.

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Safe Biologics

DECEMBER 6, 2023

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.”

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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.

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Drug Channels

AUGUST 16, 2024

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.

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Big Molecule Watch

AUGUST 24, 2023

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.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

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.

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Big Molecule Watch

JUNE 7, 2024

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

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Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. We exported $ 27.8

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

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.

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Big Molecule Watch

DECEMBER 28, 2023

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.

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Big Molecule Watch

JANUARY 25, 2024

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.

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FDA Law Blog: Biosimilars

JULY 23, 2024

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.

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FDA Law Blog: Biosimilars

AUGUST 7, 2024

But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. FDA and intervenor MSN vehemently defend FDA’s approval here.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

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).

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FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

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.

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FDA Law Blog: Biosimilars

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. launch would be in early 2024. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

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Big Molecule Watch

JULY 22, 2024

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.

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Pharmaceutical Technology

JANUARY 10, 2023

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).

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FDA Law Blog: Biosimilars

AUGUST 11, 2024

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.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

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.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

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).

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Big Molecule Watch

AUGUST 25, 2023

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.

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FDA Law Blog: Biosimilars

DECEMBER 12, 2023

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.

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FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

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.

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FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

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.

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European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2024 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. British Herbal Medicine Association.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

The LDT-specific Product Codes are as follows: SCE : IVD offered as LDT, first marketed before May 6, 2024, and not modified beyond scope described in preamble to LDT Final Rule. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. By Steven J.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

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.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. DEA found in 2016 that marijuana met none of the of elements and therefore did not have a currently accepted medical use in treatment in the U.S.

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FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Labs must also begin complying with device labeling requirements (21 C.F.R. However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. Part 801) and investigational device exemption requirements (21 C.F.R.

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Labelling 64

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

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PharmaShots

MARCH 1, 2023

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.

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Big Molecule Watch

NOVEMBER 7, 2024

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.

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