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 62

Drug Channels

NOVEMBER 4, 2024

Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars.

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Biosimilars Hospitals 79

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 96

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

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 89

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 112

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 102

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

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

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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Biosimilars Pharmaceutical Manufacturing Hospitals 103

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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Biosimilars Immunity Immunization 115

Drug Channels

SEPTEMBER 24, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

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Biosimilars Labelling 52

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 57

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 62

Big Molecule Watch

OCTOBER 4, 2024

On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI (ustekinumab-aauz), a biosimilar to STELARA®. and worldwide.”

Biosimilars 62

Biosimilars 62

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 62

Biosimilars 62

Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. Click here to see the original post from January 2024. You can find our updated counting below.

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Biosimilars 52

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

Big Molecule Watch

NOVEMBER 18, 2024

On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024.

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Biosimilars Documentation 62

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 62

Biosimilars 62

Big Molecule Watch

OCTOBER 31, 2024

On October 22, 2024, Alvotech and Teva announced that SELARSDI (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. Biosimilars, stated “This development allows us to serve patients battling gastrointestinal diseases as the U.S.

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Biosimilars Labelling 62

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

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.

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Biosimilars Documentation 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.

Biosimilars 62

Biosimilars 62

Big Molecule Watch

JUNE 3, 2024

On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for its denosumab biosimilar candidate referencing PROLIA and XGEVA.

Biosimilars 62

Biosimilars 62

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 Channels

SEPTEMBER 24, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

Biosimilars 52

Biosimilars Labelling 52

Big Molecule Watch

SEPTEMBER 3, 2024

On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. Sandoz’s ENVEEZU (aflibercept-abzv) was approved by the FDA on August 9, 2024. The post Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar appeared first on Big Molecule Watch.

Biosimilars 62

Biosimilars 62

Pharmacy Times

MARCH 8, 2024

Cardinal Health released its 2024 biosimilars report, including research and in-depth analyses on legislative development, payer landscapes, and new treatments in the pipeline.

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Biosimilars 51

Big Molecule Watch

SEPTEMBER 18, 2024

On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. On July 1, 2024, Alteogen’s subsidiary, Altos Biologics, Inc., On July 1, 2024, Alteogen’s subsidiary, Altos Biologics, Inc.,

Biosimilars 57

Biosimilars 57

Big Molecule Watch

OCTOBER 30, 2024

On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab).

Biosimilars 57

Biosimilars 57

Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). For the time being, the FDA asks two questions.

Biosimilars 57

Biosimilars Documentation 57

Big Molecule Watch

OCTOBER 18, 2024

On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA ® (denosumab) that treats osteoporosis.

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Biosimilars 44

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

European Pharmaceutical Review

APRIL 30, 2024

CHMP biosimilar recommendations A positive opinion for Tofidence (tocilizumab) was adopted by the committee, indicated for rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

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Biosimilars Generic Medicine Chemotherapy Hospitals 98

Pharmacy Times

OCTOBER 2, 2024

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

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Biosimilars Diabetes 49

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