Drug Channels

JANUARY 9, 2024

For 2024, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again each excluded 600 or more drugs from their standard formularies. This year, Humira and its 13 biosimilars will provide the most intriguing formulary drama.

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Drug Channels

DECEMBER 11, 2023

One update: CVS Caremark's 2024 formulary for patient-administered autoimmune products prefers: Humira Hyrimoz (the high WAC Sandoz biosimilar) adalimumab-adaz (the unbranded, low WAC Sandoz biosimilar) Perhaps coincidentally, Sandoz products are marketed by Cordavis, the new business described in today's rerun.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

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Drug Channels

MARCH 30, 2023

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version.

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Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment.

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Drug Channels

JANUARY 19, 2022

For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. Each exclusion list contains 400 to 500 products.

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Drug Channels

APRIL 20, 2022

For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. Each exclusion list contains 400 to 500 products.

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Drug Channels

MARCH 5, 2024

WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies. Pharmacies and Pharmacy Benefit Managers.

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Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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Drug Channels

OCTOBER 17, 2022

Join your colleagues from across the industry and be part of critical, solution-focused discussions designed to help optimize distribution models and channel strategies driven by market dynamics, product types, site of care and reimbursement, all delivered by an expert speaking faculty.

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Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. How is health policy affecting the distribution channel?

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ). 2, 2020 ( DOJ Press Release ).

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Drug Channels

OCTOBER 1, 2024

Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Section V.E.

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Biosimilars Pharmacy Production FDA 40

FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.”

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The Pharma Data

JUNE 6, 2025

CSOs allow pharmaceutical firms to scale sales operations rapidly , particularly during drug launches , geographic expansions , product lifecycle extensions , and co-promotion agreements. Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage.

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Pharmaceutical Companies Compliance Pharmaceuticals International 40

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. It’s always a good idea to compare prices at different pharmacies. “2021 Generic Drug & Biosimilars Access & Savings in the U.S. What Are Generic Drugs? A: In most cases, yes.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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FDA Law Blog: Biosimilars

JUNE 5, 2023

By Dara Katcher Levy — The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions (also known as dossiers) is on the horizon. And we need your feedback! The Format was last updated to version 4.1

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

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FDA Law Blog: Biosimilars

JULY 5, 2023

As explained in the Draft Guidance, the prohibition on wholesaling “preserves important distinctions between outsourcing facilities, which are intended to compound drugs for patients whose medical needs cannot be met by approved drugs, from conventional manufacturers, which generally engage in mass manufacturing of FDA-approved drug products.”

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year. Drug Supply Chain. Communication in this area included on-line videos, webinars, summits, conferences, and international outreach.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID). This transition does not apply to Class I devices that had a Universal Product Code (UPC). Check out here and here to see if a device is classified with product codes included for these two alternatives.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Biosimilars

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. covered insulin product or vaccine). 1395w-114c(b)(4)(B)(i).

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

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Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Science Regulations Production 40

Drug Channels

JANUARY 22, 2025

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. In fact, nearly all marketed Humira biosimilars are excluded from the larger PBMs 2025 formularies.

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

This guidance was based on stakeholder feedback that the current FDA Birth Control Guide may not identify all and/or newer contraceptive products approved, cleared, or granted by FDA.

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FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

In its response to FAQs, FDA further explained that the law affected combination products and touted that “In response to the issue of misuse of pseudoephedrine-containing products, many companies are voluntarily re-formulating their products.”

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