Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

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FDA Law Blog: Biosimilars

JULY 29, 2024

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

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Drug Patent Watch

MARCH 31, 2025

To learn more about the global generic drug market, including its trends, opportunities, and challenges, check out our latest blog post: [link] What do you think is the most significant challenge facing the global generic drug market? Share your thoughts in the comments below.

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Putting Patients First Blog

MAY 26, 2023

Biosimilars briefing Event Time: 2:00 - 3:00 p.m. ET Event Location: Virtual The National Health Council invites you to join us for a webinar on the latest developments with biosimilars on Monday, June 12 at 2 p.m. This briefing will focus on the value biosimilars hold for patient communities and our health care system.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S As the co-founder of HP&M’s FDA Law Blog , Kurt often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. More information about the conference can be found here. S for reduced registration fees.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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Drug Pricing 59

Drug Channels

SEPTEMBER 28, 2021

Curl up with your favorite pumpkin-spiced blog and savor these stories harvested from the Drug Channels patch: Fresh insights about hospitals’ specialty drug profits SSR Update: Drug prices keep dropping My $0.02 Autumn is here! You can also find me on LinkedIn , where I have more than 20,000 followers.

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Big Molecule Watch

JUNE 6, 2023

On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal nocturnal hemoglobinuria (PNH) that had global sales of approximately $5 trillion last year.

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Big Molecule Watch

MARCH 28, 2025

Stay up to date on biosimilar news, applications and approvals in the greater China region by following our Big Molecule Watch China blog. The post Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer appeared first on Big Molecule Watch.

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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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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

licensing team will continue to track these issues and keep blog readers informed about state and federal licensing/registration issues that could affect them. Most of the forms in California were several years old, so be sure to check their website to review the most updated forms. Hyman, Phelps & McNamara, P.Cs

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Finally, FDA asks Congress to amend to FDCA § 505(j) to address the submission and review of drug-device combination product ANDAs, as well as drug products submitted in an ANDA that are used with devices.

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Labelling Biosimilars Drug Pricing Dosage 104

FDA Law Blog: Biosimilars

JUNE 25, 2024

Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s “experience has shown that.

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FDA Law Blog: Biosimilars

APRIL 8, 2025

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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FDA Law Blog: Biosimilars

MARCH 3, 2025

FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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Drug Development 52

FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

As we outlined in a previous blog , by FDA’s own (artificially low) estimate, the agency anticipates in will receive, in a single year: 32,160 510(k) premarket notifications; 4,210 PMAs, PDPs, Panel-Track PMA Supplements; and 4,020 de novo This is 10 times the number of submissions the agency currently receives in a year across all device types.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

FDA Law Blog readers receive a 10% discount (use FDA Law Blog promo code: D10-999-FDA25). This program lays the groundwork for understanding the patent life cycles of biopharmaceutical products and business development plans. To learn more about the program and to view the agenda, see here.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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FDA Law Blog: Biosimilars

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. In June 2023, the list expanded to include Type B End-of-Phase 2 meetings (which we blogged about here ). And there we stayed for 6 more months, until now.

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FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

The rest of this blog will focus on the Clinical Trials Grants Program. These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development.

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FDA Law Blog: Biosimilars

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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Putting Patients First Blog

DECEMBER 9, 2024

Biosimilars and Generics The formulary inclusion of biosimilars and generics is essential in reducing the costs of medications for Medicare recipients. To enable lower cost medications, CMS would require that plan formularies prioritize access to biosimilars, generics, and affordable other alternatives.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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Drug Channels

SEPTEMBER 8, 2021

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

FDA Law Blog readers can receive a 10% discount off the conference registration price. Please join Faraz in discussing the impact of the recent rules and proposed regulations on Medicaid, including CMS’s 2022 rule on multiple best prices. Also, please say hi in person or over the conference app!

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Drug Pricing 64

FDA Law Blog: Biosimilars

MAY 3, 2023

Under the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ), all final monographs (i.e., Livornese — FDA posted the last five “deemed final orders” under OTC monograph reform this week. All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA. the regulations formerly found in 21 C.F.R.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Godwin provided updated information on the presentation made the day before by another CDER official, Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office of Pharmaceutical Quality at CDER, We summarized in a blog post yesterday her comments about facilities with FDA inspections that had been classified as Official (..)

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Documentation 97

FDA Law Blog: Biosimilars

SEPTEMBER 3, 2024

Gibbs — Thank you to readers of this blog. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos. We are happy to report that fifteen new decision summaries have been posted as of August 28.

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FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

See our prior blog post on the topic here. Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions.

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Putting Patients First Blog

JULY 18, 2023

During this session, each panelist responded to audience questions on a range of topics including: biosimilars, out-of-pocket costs, PBMs, and Medicare Part D redesign. Other Blogs: The Benefits of NHC Membership 07/25/2023 Read More Why is mental health awareness foundational for diverse communities?

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