European Pharmaceutical Review

NOVEMBER 8, 2022

2) limiting the scope and number of patents asserted in litigation against proposed biosimilar entrants. 3) policing anticompetitive settlements between competing drug manufacturers. 4) prohibiting ‘product hopping’ and interference with generic and biosimilar substitutions. 5) monitoring access to biosimilars.

Biosimilars 52

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development 59

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. analyzes how marketplace dynamics of provider-administered biosimilars affect wholesalers’ gross margins. Section 4.4.

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Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! pharmaceutical distribution industry. If you would like to pay by corporate purchase order or check, please email Tamra Feldman.

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Outsourcing Pharma

JULY 24, 2024

Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.

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Pharmaceutical Manufacturing Biosimilars 52

Drug Channels

JULY 23, 2024

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below. See the second chart below.

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Pharmaceutical Commerce

JUNE 17, 2025

24 Hours in the Hub Still Matters More Chris Dowd, ConnectiveRx June 16th 2025 Article Doubling down on patient access and support fundamentals will win out over Washington’s next move.

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Express Pharma

NOVEMBER 18, 2024

The PMEC segment will highlight companies such as ACG, Cadmach Machinery, Fette India, and Parle Global Technologies, showcasing pharmaceutical manufacturing equipment. The event will feature prominent exhibitors, including Dr Reddy’s Laboratories, Biocon, Glenmark Lifesciences, Hetero Labs Limited, and Lupin, among others.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Biosimilars 52

FDA Law Blog: Biosimilars

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

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Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.

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Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”?

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Packaging Communication Hospitals Pharmaceutical Manufacturing 52

Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”?

Hospitals 52

Hospitals Packaging Communication Pharmaceutical Manufacturing 52

Pharmaceutical Commerce

JUNE 17, 2025

24 Hours in the Hub Still Matters More Raising the Alarm Financial Assistance: Matching Awareness With Action Popping the Gross-to-Net Bubble, Part IV: Extreme Examples of Who Grew the Bubble Reviewing the Most-Favored Nation Model How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing Innovation with GenAI: Lessons from Life Sciences (..)

Insurance Coverage and Processing 52

Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers.

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Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”?

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Quality Matters

JANUARY 23, 2023

Advanced manufacturing technologies The legislation also calls for HHS to support development and implementation of advanced and continuous pharmaceutical manufacturing technologies through creation of national centers of excellence. Such products include small molecule medicines, biologics and biosimilars.

Generic Medicine 52

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Express Pharma

AUGUST 13, 2024

Sustainability in the pharmaceutical sector is becoming increasingly critical. With growing awareness of the environmental impact of pharmaceutical manufacturing—such as pollution from toxic discharges—companies must adopt more sustainable practices. billion green loan to fund its purchase of Viatris’ biosimilars business.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Pharmaceutical Manufacturing 59

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FDA Law Blog: Biosimilars

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

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Pharmaceutical Manufacturing Hospitals 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Dosage 59

Dosage Pharmaceutical Manufacturing Drug Pricing 59

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.

Pharmaceutical Manufacturing 59

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FDA Law Blog: Biosimilars

JULY 18, 2023

FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites, and over two-thirds of those went to makers of non-application products. Again, the effects of the PHE lingered in this area, as FDA targeted hand sanitizer manufacturers with 31 of those 72 letters.

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Pharmaceutical Manufacturing 52

Express Pharma

NOVEMBER 26, 2024

Integrating IT with pharmaceuticals will further strengthen its role, paving the way for dominance in biologics and biosimilars. With exports nearing $27.84 billion and innovative advancements like nanoparticles and improved drug delivery systems, India continues to lead.

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PharmaShots

FEBRUARY 27, 2023

Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. There was also discussion of the PV difficulties related to structure, nomenclature/ product name, manufacturing, and manufacturing variation challenges.

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Biosimilars Diabetes Packaging Hospitals 40

Pharmacy Times

JUNE 4, 2025

The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.

Pharmaceutical Manufacturing 26

Pharmaceutical Manufacturing Pharmacy Technician Compounding Pharmacies Compounding 26

Pharmaceutical Commerce

JUNE 16, 2025

24 Hours in the Hub Still Matters More Raising the Alarm Financial Assistance: Matching Awareness With Action Popping the Gross-to-Net Bubble, Part IV: Extreme Examples of Who Grew the Bubble Reviewing the Most-Favored Nation Model How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing Innovation with GenAI: Lessons from Life Sciences (..)

Insurance Coverage and Processing 52

Insurance Coverage and Processing Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 52

Pharmacy Times

JUNE 23, 2025

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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Pharmaceutical Commerce

JUNE 16, 2025

Why It’s Time to Upgrade, and What’s at Stake John F.

Online Pharmacies 52

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Pharmacy Times

JUNE 8, 2025

This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceutical manufacturers, medication access programs, and industry representatives. In many cases, the pharmacist resolves the issue independently, escalating to the provider only when necessary.

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Pharmaceutical Commerce

JUNE 13, 2025

It is fair to say that the pharmacy benefit managers (PBMs) enabled it, but pharmaceutical manufacturers took advantage of it. PBMs contractually allowed pharmaceutical manufacturers to raise list prices within their annual contracts to a negotiated ceiling. It does indeed take two to tango.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Drug Pricing Pharmaceutical Manufacturing Biosimilars 52

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! pharmaceutical distribution industry. and Section 6.4.3. A new Section 6.2.2.

Specialty Pharmacies 40

Specialty Pharmacies Biosimilars Pharmaceutical Manufacturing Documentation 40

Pharmaceutical Commerce

JUNE 17, 2025

24 Hours in the Hub Still Matters More Raising the Alarm Financial Assistance: Matching Awareness With Action Popping the Gross-to-Net Bubble, Part IV: Extreme Examples of Who Grew the Bubble Reviewing the Most-Favored Nation Model How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing Innovation with GenAI: Lessons from Life Sciences (..)

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Hospitals Drug Pricing 52

FDA Law Blog: Biosimilars

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.)

Online Pharmacies 59

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59

Big Molecule Watch

MAY 15, 2025

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. It requires the Secretary to issue a report with recommendations on how to reduce anti-competitive behavior from pharmaceutical manufacturers.

Drug Pricing 59

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FDA Law Blog: Biosimilars

MAY 12, 2025

It sets forth three directives: HHS shall consider facilitating direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation (MFN) price. What types of drugs are to be covered: brands, generics, biologics, biosimilars, or some combination?

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STAT

MAY 20, 2025

The Department of Health and Human Services will aim to negotiate drug prices down to the lowest prices paid by peer nations, and the pricing targets will apply to brand-name drugs that don’t face competition from generics or biosimilars. Kennedy Jr. said in a statement.

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