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.

Biosimilars 239

Biosimilars Drug Pricing 239

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.

Biosimilars 100

Biosimilars Drug Pricing 100

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.

Biosimilars 97

Biosimilars 97

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.

Biosimilars 98

Biosimilars Diabetes 98

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.

Biosimilars 98

Biosimilars 98

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. .”

Biosimilars 97

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

Biosimilars 98

Biosimilars 98

Big Molecule Watch

SEPTEMBER 15, 2023

Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar medicines. healthcare system, including patients, employers and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and biosimilar drugs, per the AAM’s report. for brands.

Biosimilars 69

Biosimilars Prescription Filling 69

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

Biosimilars 105

Biosimilars Diabetes 105

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.

Biosimilars 79

Biosimilars 79

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.

Biosimilars 98

Biosimilars 98

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 ®.

Biosimilars 104

Biosimilars Diabetes 104

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.

Biosimilars 114

Biosimilars 114

Drug Channels

JANUARY 19, 2022

For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Each exclusion list contains 400 to 500 products.

Biosimilars 94

Biosimilars 94

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.

Biosimilars 97

Biosimilars Hospitals 97

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 (!)

Biosimilars 80

Biosimilars 80

European Pharmaceutical Review

DECEMBER 13, 2022

Interchangeability of biosimilars in the EU – the industry impact. The post <em>European Pharmaceutical Review </em> Issue 6 2022 appeared first on European Pharmaceutical Review. Arnaud Robert and Brendan O’Callaghan, Sanofi. Patient-centred pharmaceutical packaging: are we there yet? REGULATORY INSIGHT.

Packaging 98

Packaging Biosimilars Drug Development 98

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.

Biosimilars 86

Biosimilars 86

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.

Biosimilars 73

Biosimilars 73

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.

Biosimilars 92

Biosimilars 92

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.

Biosimilars 59

Biosimilars Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

European Pharmaceutical Review

NOVEMBER 14, 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. Read highlights from the CHMP’s September 2022 meeting.

Vaccines 98

Vaccines Biosimilars Generic Medicine 98

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.

Biosimilars 72

Biosimilars 72

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.

Biosimilars 179

Biosimilars Drug Pricing 179

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.

Biosimilars 75

Biosimilars 75

Drug Channels

APRIL 20, 2022

Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. d/b/a Drug Channels Institute.

Biosimilars 84

Biosimilars 84

Pharma Pathway

DECEMBER 7, 2022

Hetero Limited-Campus Placement Drive for Freshers -Production/ QA/ QC/ R&D On 9th, 13th, 17th, 22nd December 2022. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. Campus Placement Drive for Freshers -Production/ QA/ QC/ R&D On 9th, 13th, 17th, 22nd December 2022.

Biosimilars 87

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 87

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.

Biosimilars 79

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 79

Pharmaceutical Technology

MAY 19, 2023

Rituxan’s success made it a prime target for biosimilar developers. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007. The first approved biosimilar in the US and EU was Celltrion/Teva Pharmaceutical’s Truxima/Blitzima in 2018 and 2017, respectively.

Biosimilars 59

Biosimilars 59

Drug Channels

JANUARY 28, 2022

Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Biosimilars 79

Biosimilars 79

Pharma Pathway

SEPTEMBER 13, 2022

Hetero Labs Limited-Walk-In Interviews for QA/ Production 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.

Biosimilars 80

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80

Pharma Pathway

SEPTEMBER 21, 2022

Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. On 24th Sept’ 2022 @ Hetero Labs Ltd. Passout: 2020, 2021, 2022. Job Description.

Biosimilars 83

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 83

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.

Biosimilars 80

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80

Pharma Pathway

DECEMBER 3, 2022

Hetero Labs Limited-Walk-In Interviews for Production/ Production Packing/ QA/QC / Engineering On 10th & 11th Dec’ 2022. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. Date of Interview: 10th & 11th Dec’ 2022. Job Description.

Biosimilars 86

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 86

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.

Biosimilars 79

Biosimilars 79

Pharma Pathway

SEPTEMBER 13, 2022

On 16th 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. On 16th Sept’ 2022 @ Hetero Labs Ltd.

Biosimilars 78

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 78

European Pharmaceutical Review

SEPTEMBER 21, 2022

Biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population. The post EMA human medicines committee (CHMP) highlights, September 2022 appeared first on European Pharmaceutical Review.

Vaccines 98

Vaccines Generic Medicine Biosimilars 98