Safe Biologics

JUNE 6, 2024

Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. View the resource guide here.

Biosimilars 100

Biosimilars Labelling 100

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.

Biosimilars 56

Biosimilars Labelling Diabetes 56

Big Molecule Watch

MARCH 27, 2023

Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. On March 20, 2023, Coya Therapeutics, Inc. (“ Coya ”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr.

Biosimilars 72

Biosimilars Labelling 72

PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

The SIUU Guidance introduces two new concepts that are of note to industry regarding information it may choose to disseminate under this “safe harbor:” 1) application to firm-generated presentations of scientific information; and 2) material that meets a new evidentiary standard – scientifically sound and clinically relevant.

Labelling 64

Labelling Communication 64

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Labelling 45

Labelling 45

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling 40

Labelling Vaccines Communication 40

FDA Law Blog: Biosimilars

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

Labelling 40

Labelling 40

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

Labelling 40

Labelling Packaging 40

Pharma in Brief

AUGUST 9, 2021

Generic drugs and biosimilars are not eligible for this application pathway. The Minister would also have the ability to suspend the sale of an individual lot where there is evidence that it would present an unacceptable risk to Canadians’ health and safety, rather than suspend the drug’s authorization. Biologic Drugs.

Labelling 98

Labelling Packaging Biosimilars 98

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. Here are some of the top regulatory developments from 2024.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

FDA Law Blog: Biosimilars

AUGUST 11, 2024

Presenting only information about the benefits or efficacy of a prescription drug, like AUVI-Q, without any risk information is considered a false or misleading presentation under the Federal Food, Drug and Cosmetic Act (FDCA), and is considered misbranding of the product.

Labelling 59

Labelling Communication 59

Express Pharma

JUNE 28, 2024

Both India and Turkey are rising in this field, presenting significant trade and cooperation opportunities In 2022, the global pharmaceutical market reached a value of $ 1.5 The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals. trillion, with Turkey ranking 21st.

Packaging 105

Packaging Biosimilars Labelling Vaccines 105

FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

While treating rare diseases presents significant challenges due to small patient populations and limited financial incentives, the Orphan Products Grants Program provides crucial financial support to help bridge the gap between early research and successful treatment development.

Drug Development 69

Drug Development Labelling 69

FDA Law Blog: Biosimilars

AUGUST 16, 2023

In this most recent Warning Letter, however, OPDP did not take issue with ANY of the safety information presented about Breztri in the sales aid; rather, objections were focused solely on false or misleading claims related to efficacy. OPDP first took issue with a headline and graph presented on page 7 of the 12-page brochure.

Labelling 52

Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. Thus, regardless of the technicality of an initial notification letter stating approval on September 30, 2022, Taiho was prohibited under the FDCA from marketing LYTGOBI with false labeling, 21 U.S.C.

Labelling 59

Labelling Controlled Substances 59

FDA Law Blog: Biosimilars

JULY 7, 2024

10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] With respect to the UDI requirement, FDA regulations require them to be placed on the device “label.”

Labelling 64

Labelling Communication Documentation 64

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence. Advantage, OPDP. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.

Labelling 59

Labelling Adverse Reactions Dosage 59

FDA Law Blog: Biosimilars

MAY 8, 2023

FDA recommends manufacturers submit each modification, associated labeling changes and specific performance evaluation in the Modification Protocol (MP). Update procedures : The MP should describe how the manufacturer will update the software and any associated labeling that will be required for the modifications.

Documentation 98

Documentation Labelling 98

FDA Law Blog: Biosimilars

AUGUST 13, 2023

The information is presented in a Q&A format. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e., As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

Documentation 75

Documentation Packaging Communication Labelling 75

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.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

FDA Law Blog: Biosimilars

JUNE 27, 2023

We have seen companies submit screenshots of social media sites making misleading promotional claims, pictures of violative product labeling, and evidence of damaged or uncalibrated manufacturing equipment. FDA could present this information in a Frequently Asked Questions (FAQ) section, like it uses on other webpages describing its programs.

Documentation 59

Documentation Labelling Communication 59

pharmaphorum

NOVEMBER 10, 2022

We can talk all the time, Montserrat said, but now is the time for action: early diagnosis, access to the best treatments, innovation, in addition to protection of intellectual property (IP), and after that biosimilars and generics. However, experience of the healthcare system differs between regions. The responsibilities of pharma.

Vaccines 97

Vaccines Biosimilars Labelling Pharmaceutical Companies 97

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).

Labelling 40

Labelling Documentation 40

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. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. Recap of eSTAR eSTAR is an interactive PDF form designed to assist users in creating a “complete” submission. These content elements precisely follow the De Novo request content described in 21 C.F.R.

Documentation 52

Documentation Labelling 52

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 ). The FC’s decision has been appealed.

Biosimilars 52

Biosimilars Dosage Compounding Labelling 52

FDA Law Blog: Biosimilars

JUNE 28, 2023

CVM held this listening session to get feedback on how it could modernize or improve PPM 1240.3605, what challenges the current approach presents, and what additional types of claims or ingredients should be considered.

Labelling 45

Labelling 45

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

To request an FEI Number, laboratories will need to provide a long list of identifying information to FDA via email ( feiportal@fda.hhs.gov ) ( see slide 23 of the FDA’s presentation for the complete list). FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2.

Labelling 64

Labelling Communication 64

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

The letter described the mechanics and timing of the meeting, laying out a 2-hour agenda, with 50 minutes dedicated to a presentation by Oncopeptides. Marks referring to an upcoming October 2, 2023, joint (virtual) meeting with CDER and Oncopeptides.

Documentation 59

Documentation Labelling Drug Development 59

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The same underlying factors that make an adequate and well-controlled trial a robust and reliable source of evidence in the setting of an approved indication or indication submitted for concurrent approval would also be present even if the indication is not currently under review. In these recent experiences (i.e.,

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

PharmaShots

APRIL 3, 2023

The safety profile was consistent with prior reported studies with no new safety signals & the results will be presented at an upcoming medical meeting & discussed with regulatory authorities The company has a comprehensive clinical development program in EC. APN-1607 & APN-005 for neurodegenerative disease. vs 9.2mos.)

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. See 21 U.S.C.

Compounding 52

Compounding Hospitals Labelling 52

Putting Patients First Blog

JANUARY 27, 2025

However, the scope and complexity of the proposed rule may present implementation challenges. 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.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

FDA Law Blog: Biosimilars

JANUARY 22, 2025

Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? By Jeffrey N. Other than anyone under 50, that is.

Labelling 59

Labelling Communication 59

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.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130