Express Pharma

NOVEMBER 13, 2024

The 17th edition of CPHI & PMEC India, organised by Informa Markets in India, returns in an advanced format, scheduled from November 26-28, 2024, at the India Expo Centre, Greater Noida, Delhi-NCR. India’s pharma industry is on an impressive growth trajectory, expected to reach $65 billion by 2024 and to double to $130 billion by 2030.

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Express Pharma

MAY 20, 2025

Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, announced that its commercial partner in Japan, Yoshindo, has launched Ustekinumab BS Subcutaneous Injection [YD], a biosimilar to the reference product Stelara (ustekinumab).

Biosimilars 101

Biosimilars 101

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

Big Molecule Watch

NOVEMBER 7, 2024

On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). Stay up to date on biosimilar news, applications and approvals in China by following our Big Molecule Watch China blog.

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pharmaphorum

MAY 10, 2024

An insightful interview with Peter Stenico, global head of biosimilars and country president, Sandoz Austria at Reuters Pharma Europe, Barcelona 2024

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Biosimilars 118

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

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

European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

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Big Molecule Watch

MARCH 12, 2025

On March 3, 2025, Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars referencing Amgens PROLIA and XGEVA. There are currently three FDA-approved denosumab biosimilars: Sandoz s JUBBONTI and WYOST, approved on March 5, 2024, Samsung Bioepis Co.,

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Biosimilars 52

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

Big Molecule Watch

JUNE 2, 2025

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without intervention of the prescribing health care provider. mL, 40 mg/0.8 mL) prefilled syringes and single-dose vials.

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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

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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Drug Channels

DECEMBER 9, 2024

During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state. As you will see below, CVS Healths formulary actions led to rapid uptake of a low-list-price biosimilar.

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Biosimilars Labelling 52

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 100

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

STAT

JULY 15, 2024

In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.

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Drug Pricing Biosimilars Diabetes 288

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.

Biosimilars 100

Biosimilars 100

Safe Biologics

JULY 16, 2024

WASHINGTON, July 16, 2024 – The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. In the U.S., In the U.S., Reilly: “While 89% of U.S.

Biosimilars 100

Biosimilars 100

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

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 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 88

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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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 328

Big Molecule Watch

SEPTEMBER 3, 2024

Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions.

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Biosimilars Immunity Immunization 69

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 245

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

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 110

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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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 65