STAT

FEBRUARY 14, 2024

It’s been one year since the launch of the first adalimumab biosimilar for Humira in the United States, which was  followed by  eight additional adalimumab biosimilar launches. Biosimilars  are safe and effective treatments referencing biologic drugs. They If they fail to act, the U.S.

Biosimilars 349

Biosimilars 349

STAT

AUGUST 1, 2024

All of this oversight momentum is evidence that the PBM Monopoly actively denies patients access to lower-cost, safe, and effective drugs — including biosimilars. The House Committee on Oversight and Accountability also released a report that found PBMs steer patients towards higher-cost prescription drugs. Read the rest…

Biosimilars 272

Biosimilars 272

STAT

JULY 18, 2023

Now that biosimilar versions of Humira are starting to arrive, what happens next? Will this finally prove the case that biosimilars can deliver on big health care savings? What key signals will indicate how biosimilars might be prescribed, or paid for? Read the rest…

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Biosimilars Drug Pricing 246

STAT

JUNE 1, 2023

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.

Biosimilars 362

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 362

Drug Patent Watch

OCTOBER 17, 2024

Regulatory Considerations for Biosimilar Analytical Similarity Assessments Biosimilars, or follow-on biologics, are biopharmaceuticals that are highly similar to an already approved biological product.

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Biosimilars 92

STAT

SEPTEMBER 24, 2024

Regeneron has accused Amgen of infringing dozens of patents with a biosimilar version of Eylea called Pavblu. Regeneron has sued several other competitors over their proposed Eylea biosimilars, and brought its lawsuit against Amgen in January. Eylea earned Regeneron $5.89 billion in U.S. sales in 2023.

Biosimilars 257

Biosimilars 257

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. In the U.S. In the U.S.

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Biosimilars Documentation 100

STAT

MARCH 18, 2024

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products.

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Biosimilars Drug Pricing Documentation Pharmaceutical Companies 363

STAT

MAY 13, 2024

industry trade group following a dispute over allegations that the company inappropriately marketed a biosimilar medicine. At issue was an anonymous complaint filed in May 2023 by a physician who contended that Sandoz unfairly attempted to promote a biosimilar version of Tysabri for treating multiple sclerosis as an affordable option.

Biosimilars 278

Biosimilars 278

Safe Biologics

SEPTEMBER 27, 2024

Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. But the safeguards physicians count on may soon be removed.

Biosimilars 100

Biosimilars 100

Safe Biologics

AUGUST 27, 2024

2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars While 89% of U.S. From 2013-2021 all 50 state legislatures passed laws restricting automatic pharmacy substitution of biosimilars ONLY to interchangeable biosimilars.

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Biosimilars 130

STAT

OCTOBER 12, 2022

Like approaching asteroids, major biosimilars for Humira and other drugs are finally due to hit the market in 2023. Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. Read the rest…

Biosimilars 246

Biosimilars 246

STAT

SEPTEMBER 23, 2022

Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. the first biosimilar was launched in September 2015. In the U.S.,

Biosimilars 246

Biosimilars Diabetes Drug Pricing 246

Safe Biologics

OCTOBER 5, 2024

Biosimilars,” which are designed to mimic these biologic medications, help create competition and lower costs. Because of this, insurers or pharmacies can’t simply switch my patients to a biosimilar without my approval, unlike with generic drugs. Congress, including Pennsylvania Sen. A recent survey of 270 U.S.

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Biosimilars 100

STAT

JANUARY 31, 2023

January 31 is set to mark the start of a watershed year for the biosimilars industry with the release of Amjevita, the first biosimilar for Humira, the world’s best-selling drug. Several more Humira biosimilars will also be released this year. health care system $133 billion in the next three years.

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Biosimilars 246

Express Pharma

OCTOBER 9, 2024

Biocon Biologics, a global biosimilars company, has released the findings of a study focused on improving the adoption of biosimilars in low- and middle-income countries (LMICs). ” The study outlines six policy recommendations aimed at increasing access to and usage of quality-assured biosimilars in LMICs.

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Biosimilars Communication Diabetes 104

Drug Patent Watch

OCTOBER 16, 2024

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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Biosimilars Drug Development 98

STAT

APRIL 16, 2024

… The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell biosimilar medicines in the U.S.

Biosimilars 271

Biosimilars 271

STAT

NOVEMBER 18, 2022

Biosimilars, a much-lauded approach to reducing drug costs in the United States, are still underused here, even as they are proving successful in Europe. market access for Samsung Bioepis, a South Korean developer and manufacturer of biosimilars, I routinely introduce our capabilities to key stakeholders in the U.S. market access.

Biosimilars 246

Biosimilars 246

Safe Biologics

NOVEMBER 30, 2023

In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here: Physician Perspectives on Interchangeable Biosimilars Interchangeable Biosimilars: Comparing Europe and the U.S.

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Biosimilars 130

Express Pharma

AUGUST 23, 2024

Lupin announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. About Armlupeg (pegfilgrastim) Armlupeg (pegfilgrastim) is a biosimilar comparable to the reference biologic drug NEULASTA (pegfilgrastim). Armlupeg is available in the form of pre-filled syringe of 6mg/0.6

Biosimilars 101

Biosimilars 101

Safe Biologics

FEBRUARY 5, 2024

On January 31st, ASBM released a fact sheet describing a variety of proposed policy changes at the state and federal level which would weaken the interchangeable biosimilar standard, or circumvent the patient protections it provides.

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Biosimilars 130

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 62

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

Biosimilars 98

Biosimilars 98

Express Pharma

OCTOBER 14, 2024

USFDA approval of IMULDOSA was granted based on the data showing IMULDOSA similarity to its reference product STELARA in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy, and that IMULDOSA adheres to current biosimilar guidance from the USFDA.

Biosimilars 103

Biosimilars 103

Express Pharma

AUGUST 5, 2024

Lupin announced the completion of a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis. Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. The post Lupin completes Phase 3 Trials for Lucentis Biosimilar appeared first on Express Pharma.

Biosimilars 95

Biosimilars Diabetes 95

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.

Biosimilars 62

Biosimilars Diabetes 62

pharmaphorum

OCTOBER 10, 2024

The Inflation Reduction Act (IRA) has provided a positive boost for biosimilars, leading to increased accessibility and affordability. Learn more about the impact of this legislation on the healthcare industry.

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Biosimilars 72

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

European Pharmaceutical Review

APRIL 11, 2024

Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. As of September 2022, there were around 39 biosimilars approved and 22 marketed, the report stated. million by 2032, at 17.6 percent CAGR between 2023 and 2032.

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Biosimilars 105

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 Immunization Immunity 115

European Pharmaceutical Review

MAY 29, 2024

The European Commission (EC) has granted the first approval for an omalizumab biosimilar in Europe. Omlyclo ® (CT-P39) is authorised as a biosimilar referencing Xolair ®. Eculizumab biosimilar gets positive CHMP opinion The post Two novel biosimilars approved in EU and US appeared first on European Pharmaceutical Review.

Biosimilars 98

Biosimilars Immunization Immunity 98

European Pharmaceutical Review

NOVEMBER 16, 2023

While Europe has historically been a pioneer in the adoption of biosimilars, a new report by the global initiative Act4Biosimilars has revealed differences country by country, including disparities between Eastern and Western Europe. This is based on research from a report published in April this year by IQVIA.

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Biosimilars 110

European Pharmaceutical Review

APRIL 16, 2024

A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Initiation of the licensing agreement will help Teva to grow its biosimilar pipeline. Therefore, there has been “increased competition and price pressure, driving the growth of the biosimilar market”.

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Biosimilars 97

European Pharmaceutical Review

NOVEMBER 30, 2023

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Europe’s biosimilars market In Europe, Biocon Biologics portfolio includes seven biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab , Adalimumab , and Etanercept.

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Biosimilars 111

Express Pharma

JULY 29, 2024

Dr Reddy’s Laboratories, has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI) in European markets.

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Biosimilars 93

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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Biosimilars Dosage Labelling 98