PharmExec

MAY 6, 2025

Blake Powers, CEO, medigi, explains how digital tools, AI, and automation are streamlining access to biosimilars and cell and gene therapies, signaling a shift toward more tech-enabled, patient-centric care.

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Biosimilars 52

Big Molecule Watch

JANUARY 27, 2025

On January 10, 2025, Teva Pharmaceutical Industries Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI (eculizumab-aagh), Samsungs biosimilar of Soliris, in the United States. Stay tuned to Big Molecule Watch for more biosimilars licensing updates. and Samsung Bioepis Co.,

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Biosimilars 59

Big Molecule Watch

JUNE 2, 2025

On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMAs Committee for Medicinal Products for Human Use (CHMP) had issued positive opinions for Freseniuss two denosumab biosimilar candidates. The post EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars appeared first on Big Molecule Watch.

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Biosimilars 52

European Pharmaceutical Review

MAY 27, 2025

Application withdrawals Despite the CHMP granting two positive opinions for biosimilars to treat osteoporosis, an initialmarketing authorisationapplication for Teriparatide Ascend (teriparatide) intended for this indication, was withdrawn. The post CHMP meeting highlights – May 2025 appeared first on European Pharmaceutical Review.

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Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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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

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. According to Amneal, the FDA has set a target action date in Q4 2025. Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss.

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Biosimilars 52

pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The safety and immunogenicity profile of the biosimilar was also comparable to Alexion’s drug, said Amgen.

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PharmaVoice

MAY 13, 2024

As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.

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Biosimilars 130

European Pharmaceutical Review

APRIL 2, 2025

The European Medicines Agency (EMA) has published a new draft reflection paper , which discusses reducing the quantity of clinical data needed for development and regulatory approval of biosimilars. This is part of the agencys work to improve the development and assessment of biosimilar medicines, while maintaining EU safety standards.

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Biosimilars 52

Pharma Marketing Network

MARCH 20, 2025

With the rapid expansion of digital platforms, evolving patient expectations, and the increasing role of AI-driven marketing, pharmaceutical companies and healthcare brands are allocating more resources to advertising in 2025. The introduction of new drugs, biosimilars, and specialty treatments has led to increased promotional spending.

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Pharmaceutical Business Review

MARCH 4, 2025

This approval covers all indications of the reference products and the biosimilars are anticipated to be available by June 2025 in the country as per the settlement agreement with Amgen. The post FDA approves Celltrions biosimilars for various indications appeared first on Pharmaceutical Business review.

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Biosimilars 52

Pharmaceutical Technology

OCTOBER 1, 2024

Otulfi is the fourth Stelara biosimilar approved in the US but will not launch until early 2025.

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Biosimilars 105

STAT

AUGUST 30, 2023

government’s initial approach to negotiating drug prices could discourage cheaper biosimilar versions of more complex pharmaceuticals that eat up a high portion of total Medicare spending , Bloomberg Law explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.

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Express Pharma

MARCH 7, 2025

Biocon Biologics announced the successful results of a pivotal Phase 3, randomised, double-blind, parallel group, multicenter study comparing Yesintek (Biocon Biologics biosimilar to Ustekinumab, called YESINTEK) with reference product Stelara (Ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis (PsO).

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Biosimilars 52

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.

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Big Molecule Watch

APRIL 11, 2025

On April 10, 2025, Biocon Biologics Ltd. Food and Drug Administration (FDA) has approved JOBEVNE (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN .JOBEVNE Approved in 2021 in both Canada and Europe, Biocon’s bevacizumab biosimilar is already available in both markets under the name ABEVMY.

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Biosimilars 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

Pharma Marketing Network

MAY 22, 2025

Selecting the right pharma marketing vendor in 2025 is no longer a simple matter of comparing capabilities or price points. Whether youre launching a blockbuster brand like Tirzepatide or navigating market access challenges for a biosimilar, your vendors expertise can directly impact your outcomes. Choose wisely.

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Communication Biosimilars 52

Drug Channels

MARCH 26, 2025

on April 4, 2025, from 12:00 p.m. Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Coming soon: PBM Industry Update: Trends, Challenges, and Whats Ahead.Our first webinar of the year will tackle the most controversial drug channel participants. Join Adam J. Fein, Ph.D., to 1:30 p.m.

Biosimilars 52

Biosimilars 52

Express Pharma

MAY 4, 2025

Biocon Biologics has secured multiple market access agreements for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab). Cigna has added Yesintek to its commercial formulary beginning on March 21, 2025. CVS Health has added Yesintek beginning July 1, 2025. The available presentations are 45 mg/0.5

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Express Pharma

OCTOBER 14, 2024

Accord anticipates a commercial launch of IMULDOSA in the first half of 2025. The post Accord BioPharma’s Biosimilar IMULDOSA gains USFDA approval for treatment of chronic inflammatory conditions appeared first on Express Pharma. The FDA approved IMULDOSA for all indications of its reference medicine, STELARA.

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Biosimilars 105

pharmaphorum

FEBRUARY 28, 2022

India’s Biocon has expanded its pipeline of biosimilars with a $3.3 Biocon’s partnership with Mylan – which merged with Pfizer’s Upjohn to form Viatris in 2020 – dates back more than a decade and has generated a number of biosimilars including insulin analogues, antibodies and recombinant proteins.

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Big Molecule Watch

MARCH 6, 2025

On March 5, 2025, the U.S. Celltrion) from launching CT-P42, its aflibercept biosimilar of EYLEA. Celltrions aflibercept biosimilar, CT-P42, has not yet been approved by the FDA. Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing BPCIA litigations and the biosimilars market.

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Biosimilars 64

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

European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. The contact is valued at some $411 million, according to a company filing.

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Biosimilars 98

European Pharmaceutical Review

MAY 22, 2024

The European Commission (EC) has approved the first and only biosimilar versions of the reference medicines Xgeva ® and Prolia ® in Europe. About the denosumab biosimilars Wyost and Jubbonti both contain the same active ingredient (denosumab), a human monoclonal antibody.

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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 86

STAT

NOVEMBER 1, 2023

The FDA approved Amgen’s biosimilar version of Johnson & Johnson’s blockbuster psoriasis treatment, Stelara, for multiple inflammatory diseases , Reuters says. But Public Citizen maintains Medicare officials should consider the ongoing cost of the patenting tactics when negotiating a price. billion in 2022.

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Biosimilars 294

Big Molecule Watch

FEBRUARY 7, 2025

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizationsforthree biosimilar productsAmgens PAVBLU and SKOJOY, and CuraTeQ Biologics DYRUPEG.

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Biosimilars Chemotherapy Diabetes 59

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.

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Biosimilars 64

Pharmaceutical Technology

MARCH 5, 2025

Sales in Sandozs biosimilar business grew 30% buoyed by US launches including Humira-biosimilar.

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Biosimilars 59

Express Pharma

MARCH 16, 2025

To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

Express Pharma

APRIL 21, 2025

Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. In markets like China, where healthcare reforms have actively promoted biosimilars, physicians may feel more confident in involving patients in these decisions.

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Biosimilars 71

STAT

AUGUST 27, 2024

Cigna plans to remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement in 2025, and recommend less-pricey biosimilar versions of the medicine instead , Reuters tells us. This is the second major U.S. Continue to STAT+ to read the full story…

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Express Pharma

APRIL 14, 2025

At the recently held 2025 American Academy of Neurology (AAN) meeting, Remegen presented positive Phase III results for telitacicept in patients with AChR+ or MuSK+ generalised myasthenia gravis (gMG). The B cell-targeting therapy demonstrated a favorable efficacy and safety profile over 24 weeks, showing clinically meaningful improvement.

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Drug Channels

FEBRUARY 4, 2025

Outline the market access implications for provider-administered biosimilars in the buy-and-bill market. This video was excerpted from my recent Drug Channels Outlook 2025 webinar. 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Click here if you cant see the video below. All rights reserved.

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Biosimilars 52