Life Science News

Ninth Edition of Amgen's Biosimilar Trends Report Examines the U.S. and Global Marketplace with Biosimilars

Amgen (NASDAQ:AMGN) today released the 9 th edition of its Biosimilar Trends Report, which examines the current and future state of the U.S. marketplace with biosimilars. This year, in addition to examining important trends in the U.S., the Report also highlights key considerations and learnings from the global marketplace with biosimilars. To access the full Report, visit https:www.amgenbiosimilars.comcommitmenttrends-report .

"Our 2022 Biosimilar Trends Report found that the marketplace with biosimilars is well established, and the U.S. is poised to see continued growth in biosimilar approvals. This is good news for patients, physicians and payers, as the successful adoption of biosimilars has increased competition and generally lowered treatment costs associated with biologic medicines," said Jen Norton , vice president and head of U.S. Value & Access at Amgen.

New data from the Report confirm that biosimilar uptake in the U.S. continues to increase over time, resulting in significant market share in most therapeutic areas where biosimilars have been introduced. In fact, for therapeutic areas that have had biosimilars launch in the last three years, the average biosimilar share was 75 percent compared to 39 percent in the preceding three years. 1

"The trends highlighted in the Report underscore that it's an exciting time for the marketplace with biosimilars. As biosimilars become more widely available in the U.S., they have the potential to help to control costs for patients, payers and health systems," said Chelsee Jensen , pharmaceutical formulary manager at the Mayo Clinic.

The Report also discusses biosimilars' potential to expand access to treatment options that may lower healthcare costs. 2 In particular, the Report found:

  • Trends show an increase in savings per quarter, and in Q2 alone, savings in drug spend due to biosimilar availability are estimated to be $3.2 billion . 3
  • Biosimilars primarily covered under the medical benefit have typically launched at a wholesale acquisition cost (WAC) that is generally 10% to 57% lower than that of the reference product. 4
  • There are currently seven FDA-approved biosimilars for the reference product HUMIRA, with the possibility of seven or more launches in 2023 . The entry of biosimilars is expected to lead to price declines across all products within the class. 5

"Biosimilars are another potential treatment option for the millions of Americans living with inflammatory-bowel disease (IBD)," said Laura Wingate , executive vice president, Education, Support & Advocacy, Crohn's & Colitis Foundation. "We are excited about the potential expansion of biosimilars in the U.S. as we know how important it is for patients to have a variety of options."

About Amgen Biosimilars
Amgen is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com .

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index.  In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen .

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd.,  or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, the Teneobio, Inc. acquisition, or the recently announced proposed acquisition of ChemoCentryx, Inc., as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen, Thousand Oaks
Kelley Davenport , 202-834-8347 (media)
Jessica Akopyan , 805-440-5721 (media)
Arvind Sood , 805-447-1060 (investors)

1 Data on file, Amgen; Biosimilar Market Share Trends; July 2022 .
2 IQVIA (2018). The Impact of Biosimilar Competition in Europe . PDF file. Retrieved from: https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf
3 Data on file, Amgen; Biosimilars Spend Analysis; July 2022 .
4 Data on file, Amgen; Reference Product and Biosimilars - WAC and ASP Price; July 2022 .
5 Xcenda (2022). Biosimilar approval and launch status in US. Retrieved from: https://www.xcenda.com/biosimilars-trends-report

Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/amgens-annual-trends-report-finds-competition-created-by-biosimilars-contributed-21-billion-in-us-healthcare-system-savings-301646420.html

SOURCE Amgen

News Provided by PR Newswire via QuoteMedia

AMGN
bctx stock

BriaCell Appoints Renowned Pharmaceutical Veteran Jane Gross, Ph.D. to its Board of Directors

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer and other cancers, is pleased to welcome the appointment of Jane Gross, Ph.D. to its Board of Directors.

Dr. Jane Gross is a highly experienced biotech executive with over 30 years in leading research and development teams from discovery through preclinical evaluation and clinical development of therapeutics for the treatment of cancer and autoimmune and inflammatory diseases. Dr. Gross currently serves as an Independent Director for aTyr Pharmaceuticals (Nasdaq: LIFE), a biotechnology company developing novel therapeutics for respiratory diseases and multiple cancer indications.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Esperion Stock Increases After Investors Learn of Short FDA Approval Process

Esperion Therapeutics (NASDAQ:ESPR) shares increased by more than 10% after investors learned that the FDA will not require a long-term outcomes study prior to its potential approval of the company’s cholesterol-lowering drug.
According to Fierce Biotech:

Investors and analysts have been fretting over exactly what the FDA will do with ETC-1002, an LDL-lowering pill that is angling for a share of a blockbuster market many believe lies in wait for a new class of PCSK9 drugs. While the oral ETC-1002 may not be as effective as the PCSK9 drugs, including the newly-approved Praluent from Regeneron ($REGN) and Sanofi ($SNY) as well as a rival Amgen ($AMGN) drug, it also has a shot at grabbing a significant share of the market with a less expensive and more easily managed drug that could do everything many patients in this huge market require.
Overhanging all of these drugs has been a persistent fear that regulators would require a long-running cardiovascular outcomes trial to prove the therapy works as expected in improving patients’ health. But according to Esperion, the agency says it’s ready to give it a green light for a relatively narrow market–which still amounts to a patient pool of 9 million people–and then hold back on a broader approval until after the CVOT data comes in later.

Keep reading...Show less

The Impact of Inaction - New Publication Reveals Not All of Canada is on Track to Meet Global Hepatitis C Elimination Goal

  • Timing of elimination of the hepatitis C virus (HCV) in Canada's provinces indicates 70% of provinces could reach the World Health Organization's (WHO) HCV elimination target of 2030, however three of Canada's provinces — two of them the most populous in the country — are off track to achieve this hepatitis C elimination goal. 1
  • Timely elimination would save 170 lives and $122.6 million in direct medical costs in these three provinces by 2030. 1
  • The Progress Report developed by Action Hepatitis Canada outlines key metrics on which to evaluate HCV elimination progress in Canada , specific to each province. 2
  • In Canada , there are five priority populations and one age-cohort that carry the largest burden of HCV and are recognized as being affected the most by the virus.

ABBVie (NYSE: ABBV) supports a wide range of efforts to help elevate and prioritize hepatitis C virus (HCV) elimination. With a recent publication indicating 70% of Canada's provinces are on track to reach HCV elimination by the World Health Organization's (WHO) initial proposed target of 2030 1 it is important to turn our attention on those affected by the virus and acknowledge that infection with chronic HCV is a global public health concern.

The Impact of Inaction: Timing of Hepatitis C Elimination in Canada. (CNW Group/AbbVie Canada)

In 2016, Canada was one of the 194 countries that committed to support the World Health Organization's (WHO) goal of eliminating viral hepatitis as a public health threat by 2030. With the remarkable progress in HCV therapy, offering the ability to cure patients, this goal seemed possible.

"With the decline in treatment across Canada , it is particularly critical we continue to monitor treatment levels to assess Canada's progress to HCV elimination," said Jordan J Feld, MD MPH, Interim Director, Toronto Centre for Liver Disease, University Health Network, University of Toronto . "We need to continue to pursue novel approaches to case finding and linkage to care, as well as work closely with identified priority populations to ensure that they are able to seek prevention and treatment services without facing stigma and other barriers in the health care system. At the policy level, we need to improve our data sharing abilities across the country to ensure we can track our progress toward elimination."

Populations Most Affected by HCV in Canada 3

  • Indigenous people
  • People with experience in the prison system
  • People born between 1945 and 1975
  • Immigrants and newcomers
  • Gay, bisexual, men who have sex with men (gbMSM)
  • People who inject or use drugs

" Canada has made great strides toward the elimination of hepatitis C. However, there is a lot more work to be done, and the tactics that got us to this point will not necessarily get us to elimination," said Jennifer van Gennip , Executive Director, Action Hepatitis Canada. "Our mandate is to hold the federal and provincial governments accountable to provide the policies and resourced plans to achieve our goal, with focused efforts on priority populations within Canada ."

A look at national treatment data from January 2019 to November 2020 4 confirmed the decreasing trend in treatment levels nationally - a year-over-year decline of 31% in total treatment levels between 2019 and 2020. The report notes that this drop could be due to the disruptions to the healthcare system caused by the COVID-19 pandemic but could also reflect the saturation of treatment among those already linked to care and the difficulties with finding and engaging with individuals and populations not well served by our various healthcare systems. 1

"Everyone has a part to play in eliminating viral hepatitis as it will take more than medicine to achieve this goal," said Tracey Ramsay , Vice-president and General Manager, AbbVie Canada. "AbbVie is committed to partnering with stakeholders to implement sustainable solutions that allow more patients to be screened, linked to care, and treated in a timely manner, especially for those vulnerable patient populations that have lost access to our healthcare system as a result of the pandemic."

Given the available evidence, Canada's momentum towards timely HCV elimination may be jeopardized if diagnosis and treatment are not maintained at appropriate levels. Improved HCV surveillance to build frameworks and innovative approaches to prevention, testing, linkage to care and treatment to achieve this goal is required.

About Hepatitis C

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have the disease. 5 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada . 6 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Twitter , Instagram and LinkedIn.


1 Timing of elimination of hepatitis C virus in Canada's provinces. https://canlivj.utpjournals.press/doi/full/10.3138/canlivj-2022-0003 . Accessed November 2022.


2 Action Hepatitis Canada. Progress Toward Viral Hepatitis Elimination in Canada. 2021 Report. https://www.actionhepatitiscanada.ca/uploads/8/3/3/9/83398604/ahc_progress_report_2021.pdf . Accessed November 2022.


3 Action Hepatitis Canada. Priority Populations. https://www.actionhepatitiscanada.ca/priority-populations.html . Accessed November 2022.


4 IQVIA GPM National Audit for HCV/Direct Acting Antivirals Market, January 2019–November 2020.


5 Canadian Liver Foundation. https://www.liver.ca/hepatitis-c-warning/ . Accessed November 2022.


6 Canadian Liver Foundation. https://www.liver.ca/how-you-help/advocate/ . Accessed November 2022.

AbbVie logo (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/24/c4530.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

AMGEN ANNOUNCES WEBCAST OF 2022 EVERCORE ISI HEALTHCARE CONFERENCE

Amgen (NASDAQ:AMGN) will present at the Evercore ISI HealthCONx Conference at 11:20 a.m. ET on Tuesday, November 29, 2022 . David M. Reese M.D., executive vice president of Research and Development at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") announces that, subsequent to the LOI Sirona and Wanbang Biopharmaceuticals (" Wanbang ") have signed an expanded, international partnership agreement to collaborate on licencing Sirona's SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence.

Wanbang (a wholly owned subsidiary of Shanghai Fosun Pharmaceutical) and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AbbVie to Present at the Evercore ISI HealthCONx Conference

ABBVie (NYSE: ABBV) will participate in the 5 th Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, November 29, 2022 . Rob Michael vice chairman and president, Jeffrey R. Stewart executive vice president, commercial operations, Scott Reents senior vice president and chief financial officer, and Tom Hudson senior vice president, R&D and chief scientific officer, will present at 9:55 a.m. Central time .

A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the session will be available later that day.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AbbVie Announces European Commission Approval of SKYRIZI® for the Treatment of Moderate to Severe Active Crohn's Disease

A significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo 1 2 3 - A significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance 1, 2, 3 - Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care 4, 5 ,6

NORTH CHICAGO, Ill. , Nov. 23, 2022 /PRNewswire/ -- ABBVie (NYSE: ABBV) announced the European Commission (EC) approved SKYRIZI ® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. 1,2,3

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting

- Nearly 65 abstracts, including 15 oral presentations on 7 investigational and approved medicines across 8 cancer types, to be presented at the American Society of Hemaotology (ASH) annual congress

ABBVie (NYSE: ABBV) will present results from nearly 65 company and partner abstracts across 8 types of cancer during the upcoming American Society of Hematology (ASH) annual meeting ( December 10-13 ) in New Orleans, Louisiana .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×