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. Below are some of the top regulatory developments from 2023.

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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. That litigation is ongoing.

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Big Molecule Watch

JUNE 29, 2023

As we previously reported , Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. The Court also noted that Biogen’s own expert cited sources showing that, in the 12-18 months after biosimilar launch, the price of the biosimilar product remained stable.

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FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. report certain device malfunctions, and.

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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. 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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FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Structure of the eSTAR for De Novos The draft guidance provides a table that offers a high-level overview of the structure of the eSTAR for De Novos, including elements such as the cover letter, device description, proposed indications for use, classification, benefits, risks, mitigation measures, labeling, and supporting data.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion.

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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. Increased transparency will ensure that formulary practices align with broader goals of affordability and patient access.

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pharmaphorum

JANUARY 14, 2021

CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade. Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. Focus on customer engagement impact.

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FDA Law Blog: Biosimilars

JULY 9, 2024

Would any such failure to meet DAP goals be reflected in labeling? This means, under Congress’s direction in FDORA, the FDA should be trying to finalize the Draft Guidance around June 2025. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

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Drug Channels

DECEMBER 9, 2024

This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. 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.

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Big Molecule Watch

OCTOBER 31, 2024

This new presentation allows for SELARSDI to expand its label to align with the indications of the reference product STELARA® (ustekinumab). Biosimilars, stated “This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025.”

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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 ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.

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FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

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FDA Law Blog: Biosimilars

JANUARY 14, 2025

MoCRA includes several self-executing requirements, such as registration and product listing, adverse event reporting requirements and labeling for adverse event reporting. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. FDAs report card therefore shows a big Incomplete.

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FDA Law Blog: Biosimilars

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. By Charles D. Snow & Deborah L.

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FDA Law Blog: Biosimilars

JANUARY 5, 2025

Turning first to the four areas in which changes were made, the focus of two of those areas were the requirements for the required labeling statements for a product approved with an ACNU. The final rule becomes effective on January 27, 2025. The third was the postmarketing requirement for reporting an ACNU failure.

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Express Pharma

FEBRUARY 10, 2025

India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies. A lot of the work we’ve done in many years leading up to this and would be a big driver of 2025, is how do we really start seeing and feeling the impact of new technologies in the business?

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FDA Law Blog: Biosimilars

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. 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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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. 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

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

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FDA Law Blog: Biosimilars

MARCH 6, 2025

adding labels or tags to raw data), as is done in semi-supervised or supervised machine learning, the annotation process and credentials of the annotators should be documented. The DCP should address if there are missing data elements (e.g., If the data collected will be annotated (e.g.,

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Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m. Or, just click here to order.)

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. By Allyson B. Mullen & Jeffrey N.

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