FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA 59

FDA Regulations Packaging Compliance 59

FDA Law Blog: Biosimilars

MARCH 3, 2024

Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year.

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

FDA Law Blog: Biosimilars

MARCH 8, 2023

For any major changes, additional time will be granted between the release of the implementation package and production deployment. Although FDA intends to follow this schedule, emergency fixes may be implemented outside of the schedule. Although FDA intends to follow this schedule, emergency fixes may be implemented outside of the schedule.

Packaging 59

Packaging FDA Production Regulations 59

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

The appeal of distilling down the extensive process that goes into the decision to approve an application into a single package is easy to see, and some may be interested in only the ultimate distillation – an approval is issued or not. There are those who are willing to read through the more extensive package consisting of all the reviews.

FDA 59

FDA Packaging International Drugs 59

The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.

Treatment 52

Treatment Drugs Clinical Pharmacology Clinical Development 52

FDA Law Blog: Biosimilars

JUNE 26, 2024

package labeling is optional). However, the applicant is not required to include all attachments to complete the submission (e.g.,

FDA 98

FDA Regulations Production Packaging 98

Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

Production 64

Production Compliance Regulations FDA 64

Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 2, 2024

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

FDA 40

FDA Science Regulations Biosimilars 40

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

FDA 45

FDA Drugs FDA Approval Packaging 45

FDA Law Blog: Biosimilars

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

Regulations 45

Regulations FDA Production Government 45

Agency IQ

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). If none of the 12 bills are completed, then all government operations shut down.

Government 40

Government FDA Biosimilars Regulations 40

FDA Law Blog: Biosimilars

AUGUST 17, 2023

The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. . § 314.94(a)(8)(iv),

FDA 40

FDA Production FDA Approval Regulations 40

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. What’s next? Stay tuned.

FDA 52

FDA Biosimilars Science Drugs 52

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Agency IQ

JULY 28, 2023

That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021. Revenue outside the U.S. decreased 28 percent to $95.6 million, primarily driven by decreased volume.

Production 52

Production Marketing Research Treatment 52

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Drugs 59

Drugs FDA Licensing Licensing 59

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g., CMS’ final regulation expansively defines a “misclassification” to include not only misclassifying the drug category (e.g.,

Drugs 59

Drugs Regulations International Production 59

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

APRIL 10, 2025

In some cases, previously routine postings are delayed or going unpublished altogether.

FDA 59

FDA Packaging Government International 59

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues.

Licensing 59

Licensing Licensing Pharmacy Packaging 59

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

As justification, the governors argued that state-regulated cannabis would require age verification, packaging and labeling standards, testing and warning symbols or statements, and allow for tracking products from seed to sale.

Regulations 59

Regulations Production Packaging Licensing 59

FDA Law Blog: Biosimilars

MARCH 9, 2025

John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China.

Compliance 59

Compliance Packaging Regulations FDA 59

FDA Law Blog: Biosimilars

MARCH 30, 2025

Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging.

FDA 59

FDA Packaging Production Research 59

Drug Patent Watch

JANUARY 7, 2025

When educating elderly patients: Be patient and take extra time to explain concepts Use larger print materials for easier reading Address concerns about changes in pill appearance or packaging Communicating with Young Adults Younger patients may be more open to generic drugs but might lack knowledge about how they work. ” FDA.gov, 2021.

Drugs 77

Drugs FDA Doctors Trials 77