Safe Biologics

DECEMBER 1, 2022

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The next topic will be “Ophthalmic Biosimilars” in November 2022. Watch video of the Non-Medical Switching webinar here. These webinars are the first two in a series.

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Biosimilars 130

Safe Biologics

DECEMBER 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland. ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”.

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Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S. The bifurcated U.S.

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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 87

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 85

pharmaphorum

APRIL 1, 2022

Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko.

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Biosimilars Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. billion in 2022, a product that was launched in 2002.

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Biosimilars 76

Express Pharma

JUNE 22, 2023

Healthcare professionals (HCPs) believe that biosimilars could provide costs savings for the patients and healthcare systems and their use should be encouraged, according to a survey by GlobalData. The only exception was Japan were physicians seemed to be more reluctant about biosimilar use.

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Biosimilars 85

Big Molecule Watch

MARCH 18, 2024

Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). billion in 2022. There is currently no FDA-approved biosimilar to XOLAIR (omalizumab), and Celltrion is the first company to seek marketing approval of an omalizumab biosimilar in the United States.

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Biosimilars 57

European Pharmaceutical Review

SEPTEMBER 11, 2023

has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). About the biosimilar development deal This agreement will help to expand access to biosimilar medicines , according to Samsung Bioepis. Samsung Bioepis Co.,

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Biosimilars 71

Express Pharma

AUGUST 1, 2023

The potential revenue replacing Humira has resulted in many adalimumab biosimilar offerings being brought forth (currently nine FDA-approved agents), and a rapidly overcrowded market. Against this backdrop, Cyltezo from Boehringer Ingelheim has shown the intersection of price and regulation in the biosimilar market, says GlobalData.

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Biosimilars 94

Express Pharma

SEPTEMBER 20, 2023

Biocon Biologics has received the European Commission (EC) granted marketing authorization in the European Union (EU) for YESAFILI, a biosimilar of Aflibercept. billion for the 12 months ending December 31, 2022, according to IQVIA. Aflibercept had EU brand sales of approximately $1.8

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Net prices in therapeutic classes with biosimilar competition have declined by 60% or more over the past few years. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. drug distribution.

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Biosimilars 75

Big Molecule Watch

APRIL 20, 2023

On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women at high risk of fracture. MAILISHU was developed by Mabwell’s wholly owned subsidiary, T-Mab.

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Biosimilars 70

Big Molecule Watch

DECEMBER 14, 2023

announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023. The post Recent Biosimilar Approvals appeared first on Big Molecule Watch.

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Biosimilars Diabetes 57

Big Molecule Watch

DECEMBER 13, 2023

Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA. The post Denosumab Biosimilar Updates appeared first on Big Molecule Watch.

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Biosimilars 62

Big Molecule Watch

NOVEMBER 14, 2023

District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of Commercial Marketing with respect to the same.

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Biosimilars 111

Big Molecule Watch

MAY 25, 2023

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. As we previously reported , Celltrion entered into an agreement in April 2022 with AbbVie that would allow Celltrion to market its biosimilar to AbbVie’s HUMIRA product.

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Biosimilars 73

European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States.

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Biosimilars Diabetes 87

Drug Channels

JULY 20, 2022

In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. P.S. Join my nearly 30,000 (!)

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Biosimilars 82

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%. will face multiple biosimilar competitors. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Prices are dropping while adoption accelerates.

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Biosimilars 88

Express Pharma

SEPTEMBER 6, 2023

Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America (US and Canada) effective September 1, 2023. Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris. The agreement closed in November 2022.

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Biosimilars 52

Drug Channels

JANUARY 10, 2023

Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. I also note some troubling research on the patient impact of exclusions—although much remains unknown.

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Biosimilars 94

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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Biosimilars Customer Service 102

Pharmaceutical Commerce

JANUARY 5, 2024

US biosimilars market projected to grow from less than $10 billion in 2022 to more than $100 billion by 2029.

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Biosimilars 52

STAT

SEPTEMBER 6, 2023

The Inflation Reduction Act (IRA), passed in August 2022, gives Medicare pricing power over therapies that both cost Medicare lots of money and have by 2026 enjoyed market exclusivity for a certain number of years — nine for small-molecule drugs and 13 for biologics.

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Drug Channels

DECEMBER 12, 2022

Click here to see the original post and comments from September 2022. By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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European Pharmaceutical Review

OCTOBER 14, 2022

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. More interchangeable biosimilars are estimated to be approved and launched in the US in the next few years. .”

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Biosimilars 76

Pharma in Brief

JANUARY 11, 2023

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit ( ODB ) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023. .

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Biosimilars 52

Big Molecule Watch

JULY 7, 2023

As we previously reported , in December 2022, Biocon Biologics Ltd. (a had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc. The post Biocon Completes Integration of Viatris Biosimilars Business appeared first on Big Molecule Watch. a subsidiary of Biocon Ltd.)

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Biosimilars 62

Drug Channels

AUGUST 23, 2022

on key specialty pharmacy trends Evidence for biosimilar-to-biosimilar switching Plus, Dr. Glaucomflecken takes on PBMs! Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. P.S. Join my more than 31,000 LinkedIn followers for daily links to neat stuff. d/b/a Drug Channels Institute.

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Express Pharma

JULY 23, 2023

Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar. billion for the 12 months ending December 31, 2022, according to IQVIA.

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Biosimilars Diabetes 83

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. A biosimilar for biologic ophthalmic treatments. Manufacture and development of Ximluci ®.

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Biosimilars Diabetes 82

Drug Channels

OCTOBER 25, 2022

Sink your fangs into Amgen’s fantastic new report on the biosimilar boom Wicked! Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Mark Cuban tells ghost stories about PBMs. Walgreens terrifies Wall Street with its 340B losses. Physicians think payers cast evil utilization management spells. d/b/a Drug Channels Institute.

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Biosimilars 84

Pharma Pathway

SEPTEMBER 16, 2022

Hetero Labs Limited-Campus Placement Drive for Freshers On 17th Sept’ 2022. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar.

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Pharma Pathway

DECEMBER 13, 2022

Hetero Labs Limited-Walk-In Interviews for Freshers in QA/ QC On 14th Dec’ 2022. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar.

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Drug Channels

OCTOBER 14, 2022

Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. Read on for Steve’s insights. d/b/a Drug Channels Institute.

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Biosimilars 81