FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

The LDT Rule itself provides no operational guidance, but only a definition. In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ).

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Labelling Communication 102

Safe Biologics

DECEMBER 3, 2023

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.

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Biosimilars Labelling Drug Pricing Packaging 130

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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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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Biosimilars Labelling Communication 59

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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Labelling 59

FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

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Documentation Labelling Communication 106

European Pharmaceutical Review

DECEMBER 20, 2023

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) By contrast, orphan drugs could become less profitable, more risky investments.

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Biosimilars Labelling Documentation 98

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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Biosimilars Labelling 69

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3 Subpart B reserves §§ 820.20 – 820.30, 820.40.

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Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed.

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Controlled Substances Labelling 52

FDA Law Blog: Biosimilars

JULY 23, 2024

Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery. With respect to verification and validation of EDDOs, the draft guidance recommends demonstration that the EDDO is met after preconditioning that includes conditions of storage and shipping.

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Labelling 106

FDA Law Blog: Biosimilars

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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Labelling Packaging 45

FDA Law Blog: Biosimilars

MAY 15, 2023

States frequently review labels (and labeling) for animal food products. A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law.

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Labelling Documentation 45

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. It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product.

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Drug Development Documentation Labelling Biosimilars 103

PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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Biosimilars Diabetes Labelling 40

FDA Law Blog: Biosimilars

JULY 16, 2025

The Warning Letter makes clear that FDA and WHOOP have been in discussions about the status of BPI for some time, throughout which WHOOP has maintained its position that the BPI is a general wellness product and does not meet the definition of a medical device.

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Labelling Hospitals 52

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. Drugs are considered to be “qualifying single-source drugs” if they have been without generic or biosimilar competition for a certain number of years.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

FDA Law Blog: Biosimilars

JUNE 28, 2023

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

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Labelling 45

FDA Law Blog: Biosimilars

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

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Labelling Documentation 40

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Change to the IVD definition First, the mechanics of the change. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R.

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Labelling 65

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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Packaging Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

We are not reproducing the questions that were simple recitations of regulatory definitions or FDA’s arguments in the 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.

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Labelling Communication 65

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended the definition to make clear that substantial evidence could also be demonstrated by “one adequate and well-controlled clinical investigation and confirmatory evidence.” However, the Act does not define what may constitute such confirmatory evidence.

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Drug Development Documentation Labelling Medical Records 65

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. To strengthen the proposal, the NHC recommends that CMS avoid implementing rigid definitions of overweight and obese.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. Non-applicable drugs (e.g., of the total expenditures for all Part D drugs in 2021.

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Labelling Drug Pricing Compounding Payment Processing 105

FDA Law Blog: Biosimilars

MAY 23, 2023

While the statistics were against the Supreme Court taking up the case given the limited number of cases heard per year, it’s definitely disappointing for those of us who have been watching the case for the last 7 years. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

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Labelling 40

Pharma in Brief

JANUARY 25, 2023

Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use. Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ).

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Biosimilars Dosage Labelling Compounding 52

FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. This includes newly acquired labeler codes and newly formed subsidiaries. In CMS’s terms, manufacturers must be “all in” for all of its drugs or “all out.”

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Labelling Vaccines Drug Pricing Immunization 59

FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. Marijuana” outside of the CSA definition, including hemp, mature stalks, fiber from the mature stalks, oil or cake made from seeds, and sterilized seeds incapable of germination are not controlled and not subject to the recommendation.

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Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

MAY 21, 2024

The FDA reviewed studies investigating the safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and FDA-approved products’ labeling. Basis at 63-64. HHS’ recommendation related only to marijuana as defined in the CSA.

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Controlled Substances Chemotherapy Dosage Labelling 69

PharmaShots

APRIL 3, 2023

treatments for lung cancer & advanced breast cancer Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara Date – Mar 17, 2023 Product – SB17 The P-I study evaluating SB17 (45mg) vs Stelara (US & EU sourced) via SC inj. The authorization incl. in a ratio (1:1:1) in 201 patients.

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Biosimilars Diabetes Compounding Hospitals 40

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). For foods that do not have established definitions and standards of identity (i.e., The description or name of the food (i.e.,

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Labelling Documentation Packaging 52

FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

The Court looked to the “statute’s words, structure, and historical context” and found that they “establish that, when Congress amended the [Orphan Drug Act] in 2017, it ratified and incorporated the existing regulatory definition of ‘same drug’ into the statute.”

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Labelling 111

FDA Law Blog: Biosimilars

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

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Labelling Documentation 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

The Draft Guidance acknowledges that there are some differences between the terminology used by FDA and the broader AI community, so it is important that all stakeholders review definitions and make sure they are speaking FDAs preferred language when preparing device documentation. User Interface Software Description Section VI.B

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Documentation Labelling Communication 95

FDA Law Blog: Biosimilars

MAY 26, 2025

Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. Second, the memo makes it clear that the intended investigation targets are persons and entities providing medical care, but the statutes own definition of FGM excludes such care. 116(e) (emphasis added).

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Labelling HIPAA Documentation Pharmaceutical Companies 59