Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the agenda.

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Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

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Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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Biosimilars Documentation Drug Pricing 130

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Biosimilars Drug Pricing Compounding Drug Development 100

Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S.

Biosimilars 100

Biosimilars Drug Pricing 100

FDA Law Blog: Biosimilars

APRIL 7, 2025

In a year of major change and outstanding questions, growing scrutiny on patent protection and drug pricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical. Hyman, Phelps & McNamara, P.C.s

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Drug Pricing 59

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing 100

Drug Pricing Biosimilars 100

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing 100

Drug Pricing Biosimilars 100

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That’s up to… all of us in aggregate.

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Drug Pricing Biosimilars Drug Development 52

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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Biosimilars Drug Pricing 76

Drug Channels

OCTOBER 7, 2024

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions: What are the latest legislative updates and proposed federal bills impacting PBM operations? What are the most effective strategies for spread pricing and reimbursement models?

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Drug Pricing Biosimilars 97

Drug Channels

FEBRUARY 22, 2022

On March 15, 2022, Drug Channels Institute will release The 2022 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2022 edition at special discounted prices.

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Specialty Pharmacies Drug Pricing Biosimilars Vaccines 96

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

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. Here are some of the top regulatory developments from 2024.

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Biosimilars Drug Pricing Labelling Communication 45

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. A complete agenda is available here. Hyman, Phelps & McNamara, P.C.’s

Drug Pricing 64

Drug Pricing 64

European Pharmaceutical Review

JANUARY 18, 2024

Market projections Leading treatments in the insomnia treatment market “The loss of patent exclusivity will allow cheaper generic versions of the DORAs to enter the [insomnia treatment] market” The company emphasised that at present, the US represents the largest insomnia market, with 81.9

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Drug Pricing Biosimilars Compounding 98

Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Similar echoes are heard in Europe, where pressure to curb price growth will stay a priority.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 64

Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. Although AbbVie’s Humira (adalimumab) is set to face biosimilar competition next year, the blockbuster drug reported strong US sales of $4.96

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Vaccines Diabetes Drug Pricing Biosimilars 52

Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Similar echoes are heard in Europe, where pressure to curb price growth will stay a priority.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 52

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. See Motion at 11. Order at 22.

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Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 59

Putting Patients First Blog

JANUARY 27, 2025

However, the scope and complexity of the proposed rule may present implementation challenges. Standardized templates can help eliminate ambiguities, ensuring that all essential information is presented in an accessible and user-friendly manner.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

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Safe Biologics

MARCH 10, 2025

This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. Read the full statement here.

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Biosimilars Independent Pharmacies Drug Pricing Vaccines 130