Global experience, data and improved patient access indicate strong market for future U.S. biosimilars
CHICAGO, IL, USA I April 24, 2013 I Hospira, Inc. (HSP), the world’s leading provider of injectable drugs and infusion technologies, today announced an important milestone, commemorating five years of providing biosimilars to the European market and delivery of more than five million doses of high-quality biosimilar medicines at a lower cost to patients in Europe and Australia. Biosimilars are an important industry topic at the BIO International Convention in Chicago this week, with multiple sessions devoted to topics such as biosimilar regulatory approval, manufacturing and market formation.
“Bringing biosimilars to the United States is the next major step toward reducing costs for the U.S. healthcare system,” said Thomas Moore, president, U.S., Hospira. “As the first U.S. company to market biosimilars globally, Hospira will build on our track record of success to introduce biosimilars in the United States and increase access for Americans to high-quality biologic medications that treat severe and life-threatening diseases.”
Global Experience and Data
Hospira’s biosimilars in Europe and Australia entered the markets after robust regulatory approval processes. These approvals were supported by a rigorous scientific evaluation to demonstrate the products’ therapeutic equivalence to the reference products, including an extensive clinical study program. Furthermore, Hospira’s biosimilars have been subject to extensive post-marketing studies that continue to support their safety and effectiveness in routine use.
Retacrit™, Hospira’s first biosimilar, was launched in Europe in early 2008. A total of more than 1,600 patients were studied to support intravenous (I.V.) and subcutaneous administration of the product. Retacrit is a recombinant human erythropoietin, or “EPO biosimilar.” It is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma. Hospira’s second marketed biosimilar product is Nivestim™, a biosimilar version of filgrastim (GCSF) – used for a condition known as neutropenia in which the body makes too few infection-fighting white blood cells. Nivestim entered the European market in 2010 and the Australian market in 2011.
Increased Affordability and Patient Access
Since Hospira launched its biosimilars, prices have decreased and patient access has increased.
In Europe and Australia, biosimilar treatments offer cost savings to healthcare systems of approximately 25 percent to 30 percent.1 In the United States, newer biologic treatments can cost $100,000 or more per patient, per year.2 A price decrease in the United States similar to the one experienced in Europe would benefit patients and payers alike.
A number of studies predict that successful adoption of biosimilars in the United States could result in significant savings for U.S. patients and the U.S. healthcare system driven by increased competition. A 2013 study by accounting firm Grant Thornton found that biosimilars hold the potential to save $20 billion annually in the United States.3
Market Penetration of Biosimilars and U.S. Market Formation
With the continued safe and effective record of biosimilars in European Union clinical practice, use in many markets is widespread and growing rapidly. Throughout the European Union, biosimilar versions of GCSF had gained almost 41 percent of the total daily GCSF market by the end of 2012, up from 30 percent at the start of the year.4 During the same period, EPO biosimilars had grown their market share to 19 percent of the European short-acting EPO market, up from 15 percent at the beginning of 2012.5
“Biosimilars have come to stay in Europe, and we’re very pleased with the progress we are seeing,” Hospira’s Moore said. “European and Australian physicians trust in the safety, efficacy and quality of biosimilars for their patients.”
Hospira is currently conducting a Phase III U.S. clinical trial program with its biosimilar version of EPO, which is being evaluated as a biosimilar to erythropoietin alpha. Hospira’s broad biosimilars pipeline, including products it shares with South Korean partner Celltrion, includes 11 products and is one of the largest in the industry. In 2012, Hospira filed for European approval of a biosimilar version of infliximab, a treatment for auto-immune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis. Hospira also has a biosimilar version of an oncolytic, trastuzumab, in clinical studies.
Hospira’s extensive U.S. clinical development program, coupled with its marketing track record in Europe, position the company well in its efforts to bring biosimilar products to U.S. patients.
About Hospira
Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.
Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira’s biosimilars program. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological, manufacturing supply, quality and other factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K and subsequent Forms 10-Q filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
1 Internal Hospira data
2 A. Pollack, “Biotech Firms, Billions at Risk, Lobby States To Limit Generics,” New York Times; Jan. 29, 2013
3 Generic Pharmaceutical Association press release, Feb. 1, 2013; http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton
4 IMS Midas: Dec. 2012
5 IMS Midas: Dec. 2012
SOURCE: Hospira
Post Views: 250
Global experience, data and improved patient access indicate strong market for future U.S. biosimilars
CHICAGO, IL, USA I April 24, 2013 I Hospira, Inc. (HSP), the world’s leading provider of injectable drugs and infusion technologies, today announced an important milestone, commemorating five years of providing biosimilars to the European market and delivery of more than five million doses of high-quality biosimilar medicines at a lower cost to patients in Europe and Australia. Biosimilars are an important industry topic at the BIO International Convention in Chicago this week, with multiple sessions devoted to topics such as biosimilar regulatory approval, manufacturing and market formation.
“Bringing biosimilars to the United States is the next major step toward reducing costs for the U.S. healthcare system,” said Thomas Moore, president, U.S., Hospira. “As the first U.S. company to market biosimilars globally, Hospira will build on our track record of success to introduce biosimilars in the United States and increase access for Americans to high-quality biologic medications that treat severe and life-threatening diseases.”
Global Experience and Data
Hospira’s biosimilars in Europe and Australia entered the markets after robust regulatory approval processes. These approvals were supported by a rigorous scientific evaluation to demonstrate the products’ therapeutic equivalence to the reference products, including an extensive clinical study program. Furthermore, Hospira’s biosimilars have been subject to extensive post-marketing studies that continue to support their safety and effectiveness in routine use.
Retacrit™, Hospira’s first biosimilar, was launched in Europe in early 2008. A total of more than 1,600 patients were studied to support intravenous (I.V.) and subcutaneous administration of the product. Retacrit is a recombinant human erythropoietin, or “EPO biosimilar.” It is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma. Hospira’s second marketed biosimilar product is Nivestim™, a biosimilar version of filgrastim (GCSF) – used for a condition known as neutropenia in which the body makes too few infection-fighting white blood cells. Nivestim entered the European market in 2010 and the Australian market in 2011.
Increased Affordability and Patient Access
Since Hospira launched its biosimilars, prices have decreased and patient access has increased.
In Europe and Australia, biosimilar treatments offer cost savings to healthcare systems of approximately 25 percent to 30 percent.1 In the United States, newer biologic treatments can cost $100,000 or more per patient, per year.2 A price decrease in the United States similar to the one experienced in Europe would benefit patients and payers alike.
A number of studies predict that successful adoption of biosimilars in the United States could result in significant savings for U.S. patients and the U.S. healthcare system driven by increased competition. A 2013 study by accounting firm Grant Thornton found that biosimilars hold the potential to save $20 billion annually in the United States.3
Market Penetration of Biosimilars and U.S. Market Formation
With the continued safe and effective record of biosimilars in European Union clinical practice, use in many markets is widespread and growing rapidly. Throughout the European Union, biosimilar versions of GCSF had gained almost 41 percent of the total daily GCSF market by the end of 2012, up from 30 percent at the start of the year.4 During the same period, EPO biosimilars had grown their market share to 19 percent of the European short-acting EPO market, up from 15 percent at the beginning of 2012.5
“Biosimilars have come to stay in Europe, and we’re very pleased with the progress we are seeing,” Hospira’s Moore said. “European and Australian physicians trust in the safety, efficacy and quality of biosimilars for their patients.”
Hospira is currently conducting a Phase III U.S. clinical trial program with its biosimilar version of EPO, which is being evaluated as a biosimilar to erythropoietin alpha. Hospira’s broad biosimilars pipeline, including products it shares with South Korean partner Celltrion, includes 11 products and is one of the largest in the industry. In 2012, Hospira filed for European approval of a biosimilar version of infliximab, a treatment for auto-immune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis. Hospira also has a biosimilar version of an oncolytic, trastuzumab, in clinical studies.
Hospira’s extensive U.S. clinical development program, coupled with its marketing track record in Europe, position the company well in its efforts to bring biosimilar products to U.S. patients.
About Hospira
Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.
Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira’s biosimilars program. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological, manufacturing supply, quality and other factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K and subsequent Forms 10-Q filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
1 Internal Hospira data
2 A. Pollack, “Biotech Firms, Billions at Risk, Lobby States To Limit Generics,” New York Times; Jan. 29, 2013
3 Generic Pharmaceutical Association press release, Feb. 1, 2013; http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton
4 IMS Midas: Dec. 2012
5 IMS Midas: Dec. 2012
SOURCE: Hospira
Post Views: 250
