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. Comments may be submitted here until April 30, 2024.

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Biosimilars Documentation Drug Pricing 130

Safe Biologics

DECEMBER 12, 2024

December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. The bill would automatically declare all biosimilars as “interchangeable” with their reference biologics. Press Release ARLINGTON, Va., A recent survey of 270 U.S.

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Biosimilars 100

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. All rights reserved.

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Biosimilars 98

Safe Biologics

MAY 21, 2024

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

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Biosimilars Documentation 100

pharmaphorum

OCTOBER 24, 2024

Legal win leads Amgen to at-risk launch of Eylea biosimilar Phil.Taylor Thu, 24/10/2024 - 07:07 Bookmark this

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Biosimilars 107

Express Pharma

DECEMBER 24, 2024

Namit Joshi assumed charge as Chairman of the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) during the 20 th Annual General Meeting held on December 23, 2024. He was elevated to the present post after serving two years as Vice Chairman of Pharmexcil.

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Biosimilars 105

Express Pharma

SEPTEMBER 25, 2024

Biocon Biologics , a subsidiary of Biocon announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. This in the context of multiple switches between the reference product and the biosimilar as required of an interchangeability study.”

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Biosimilars 105

Safe Biologics

JUNE 6, 2024

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM Discusses Biosimilar Interchangeability and Substitution at Oregon’s St. View the resource guide here.

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Biosimilars Labelling 100

pharmaphorum

JANUARY 24, 2025

Explore the lessons learned from 2024 in pharmacy benefits, including the impact of polypharmacy, biosimilars, and GLP-1 medications, and what to expect for 2025 in this insightful article.

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Biosimilars 99

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? Stelara biosimilars in the US market The first Stelara biosimilars are expected to enter the US market in 2025. “We

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Biosimilars 98

Safe Biologics

OCTOBER 13, 2024

Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE – September 4, 2024 Arlington, VA- U.S. physicians. physicians. In the U.S. In the U.S.

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Biosimilars Documentation 100

Safe Biologics

SEPTEMBER 27, 2024

Prioritize Patient Treatment Stability, Physician Confidence Michael Reilly September 25, 2024 Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. To date, 59 biosimilars have been approved and have saved our health system $24 billion.

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Biosimilars 100

Pharmaceutical Technology

AUGUST 24, 2023

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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Biosimilars 98

Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

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Biosimilars 97

Drug Channels

SEPTEMBER 7, 2022

As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. I also offer some thoughts on 2023 and 2024. will face multiple biosimilar competitors. Prices are dropping while adoption accelerates.

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Biosimilars 98

Safe Biologics

AUGUST 27, 2024

A 2024 survey of 270 U.S. 87% of respondents agreed that they are more comfortable switching a patient from an originator biologic to a biosimilar if that medicine has been specifically evaluated for the impact of switching on safety and efficacy. Only 11% believe all biosimilars should be deemed interchangeable. policy here.

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Biosimilars 100

Safe Biologics

OCTOBER 5, 2024

Lower med standards endangers health Altoona Mirror Opinion Oct 2, 2024 Dr. Ralph McKibbin As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision. While these drugs are safe and effective, they are not exact copies of the original biologics.

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Biosimilars 100

Express Pharma

DECEMBER 20, 2024

As of 2024, India has produced nearly half of the eight billion vaccine doses distributed worldwide, cementing its reputation as a reliable healthcare contributor. Indias life sciences industry continues to demonstrate its stature as a global powerhouse, often referred to as the pharmacy of the world.

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Biosimilars Vaccines 103

Big Molecule Watch

MARCH 6, 2025

Celltrion) from launching CT-P42, its aflibercept biosimilar of EYLEA. On June 24, 2024, the district court granted Regenerons motion for a preliminary injunction against Celltrion. Celltrions aflibercept biosimilar, CT-P42, has not yet been approved by the FDA. In that opinion, issued on Jan. 11,085,865 (865 patent).

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Biosimilars 64

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. Comments may be submitted here until April 30, 2024. Read the concept paper here.

Biosimilars 100

Biosimilars Documentation 100

European Pharmaceutical Review

JULY 1, 2024

The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). CHMP meeting highlights: April 2024 The post CHMP meeting highlights – June 2024 appeared first on European Pharmaceutical Review. EMA’s human medicines committee decided to revoke the conditional marketing authorisation for Ocaliva.

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Generic Medicine Vaccines Biosimilars 106

Big Molecule Watch

SEPTEMBER 27, 2024

Approval of Accord’s Trastuzumab Biosimilar : On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

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Biosimilars Dosage Diabetes 64

Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. and Europe. and Europe.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

Express Pharma

JUNE 28, 2024

Indian Pharmaceutical Alliance (IPA) concluded the 9th edition of the Global Pharmaceutical Quality Summit 2024. With the audits starting in July 2024, we aim to produce world-class products, as emphasized by the Prime Minister’s vision of ‘Zero defect and Zero effect.’

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Biosimilars Documentation 108

Big Molecule Watch

JANUARY 18, 2024

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The Guide to Biosimilars Litigation and Regulation in the U.S.

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Biosimilars 64

STAT

MARCH 3, 2023

Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug=pricing experts predict Lilly’s moves will not undercut those efforts.

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Drug Pricing Biosimilars 237

Big Molecule Watch

OCTOBER 4, 2024

On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ.

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Biosimilars Diabetes 64

Safe Biologics

JANUARY 6, 2024

In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

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Biosimilars 100

Big Molecule Watch

APRIL 19, 2024

On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. The post Fresenius Kabi Announces Launch of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA appeared first on Big Molecule Watch.

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Biosimilars 64

Big Molecule Watch

JUNE 5, 2024

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars.

Biosimilars 64

Biosimilars 64

Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Click here to see the original post from September 2023.

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Biosimilars Labelling 75

STAT

JANUARY 8, 2024

Sales of Bristol’s top sellers will decline significantly or vanish as generic or biosimilar medicines emerge. Patents on big-selling medicines expire, but new medicines will come to take their place. Investors may not be able to view those changes with equanimity.

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Medicine Expiration Biosimilars 287

Big Molecule Watch

MAY 25, 2023

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. As we previously reported , Celltrion entered into an agreement in April 2022 with AbbVie that would allow Celltrion to market its biosimilar to AbbVie’s HUMIRA product.

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Biosimilars 75

Big Molecule Watch

AUGUST 6, 2024

The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. The post EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting appeared first on Big Molecule Watch.

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Biosimilars Diabetes 59

Express Pharma

JULY 15, 2024

” Dr Harshit Jain, Founder & Global CEO, Doceree: “Budget 2024 is a defining moment for the pharmaceutical sector in India. Vijay Chawla, Partner and Head, Life Sciences, KPMG in India : “ The Indian pharmaceutical industry has several expectations from the Union Budget 2024.

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Medical Records Biosimilars Pharmaceutical Companies Pharmaceutical Companies 105

Drug Channels

NOVEMBER 14, 2023

Fein, CEO 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 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. Please note that our December 2023 webinar is *not* included with next year’s 2024 Video Webinar Series.)

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Drug Pricing Biosimilars 98

Big Molecule Watch

APRIL 26, 2024

On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s ’s SIMPONI (R) and SIMPONI ARIA (R). ” AVT05 has not yet received regulatory approval.

Biosimilars 72

Biosimilars 72