Safe Biologics

FEBRUARY 4, 2025

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications.

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Biosimilars Immunity Immunization 130

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

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 Companies Pharmaceutical Companies HIPAA Biosimilars 59

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

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

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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Biosimilars Labelling 98

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

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.

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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

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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Packaging Documentation Compounding 59

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

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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Biosimilars Drug Pricing 249

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

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

Express Pharma

JANUARY 3, 2025

Innovation must remain at the core of our efforts Kiran Mazumdar-Shaw, Chairperson, Biocon and Biocon Biologics Indias biopharma sector, currently valued at over $54 billion, is on a promising trajectory, and projected to reach nearly $63 billion by 2025. Indian players are still in the early stage of growth within the biosimilars segment.

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Biosimilars Vaccines Hospitals Drug Development 105

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 97

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

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

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

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 98

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

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 257

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

BioPharma Dive

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 56

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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Biosimilars Dosage 146

Big Molecule Watch

OCTOBER 23, 2024

As we previously reported , on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh).

Biosimilars 64

Biosimilars 64

Big Molecule Watch

MAY 18, 2023

The USPTO has proposed several fee changes for implementation in 2025. The post Proposed USPTO Fee Changes Could Impact PGR and IPR Filing Strategies Used by Biosimilars appeared first on Big Molecule Watch. To submit comments via the portal, commenters should enter docket number PTO–P–2023–0017 on the homepage.

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Biosimilars 80

FDA Law Blog: Biosimilars

MARCH 23, 2025

Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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Labelling 59

Express Pharma

JULY 3, 2023

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

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Biosimilars Drug Development Generic Medicine Diabetes 95

Big Molecule Watch

MARCH 6, 2024

regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). Under the agreement, Biocon can launch YESAFILI in Canada no later than July 1, 2025. patent litigation related to biosimilars of EYLEA (aflibercept) can be found on the Big Molecule Watch’s BPCIA Litigation Tracker. On March 4, Biocon Biologics Ltd.

Biosimilars 59

Biosimilars 59

Express Pharma

MARCH 3, 2025

OneSource Specialty Pharma announced the appointment of three new non-executive independent directors to its Board Dr Claudio Albrecht, Debarati Sen and Vijay Karwaleffective February 27, 2025. The directors bring leadership experience and expertise in pharma, business strategy, transformation, and M&As among others.

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Biosimilars 66

Big Molecule Watch

FEBRUARY 1, 2024

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. FDA Accepts Accord BioPharma’s BLA for Ustekinumab Biosimilar On January 4, 2024, Accord BioPharma, Inc.

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Biosimilars 49

Big Molecule Watch

JULY 25, 2024

Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability. To date, the FDA has approved thirteen biosimilar products as interchangeable.

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Biosimilars 49

Big Molecule Watch

APRIL 22, 2024

On April 16, Alvotech and Teva announced the FDA approval of SELARSDI (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). SELARSDI is now the second ustekinumab biosimilar to be approved by the FDA, following FDA approval of Amgen’s WEZLANA (ustekinumab-auub) in October 2023.

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Biosimilars 45

Big Molecule Watch

MARCH 27, 2024

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. According to HHS, “[t]his change makes the U.S. According to HHS, “[t]his change makes the U.S.

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Biosimilars 45