A coalition of 11 companies involved in the development and manufacturing of biopharmaceuticals and “biosimilar” medicines recently formed the Biosimilars Forum, a nonprofit organization dedicated to expanding patient access to biosimilars in the United States.
The founding members of the Biosimilars Forum include Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. Many of these companies also provide branded biologic products, and together the Forum has extensive expertise and experience in the science, development, manufacturing, regulation and clinical applications of biological medicines. The Forum’s mission is to evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars, according to the founders.
The recently elected officers of the Biosimilars Forum are president, Juliana Reed, vice president, global government affairs, Hospira, Inc.; vice president, Hillel Cohen, PhD, executive director, scientific affairs, Sandoz Biopharmaceuticals (a Novartis company); treasurer, Geoffrey Eich, executive director, external affairs, Amgen Biosimilars; and secretary, Stacie Phan, director, state government affairs and public policy, Boehringer Ingelheim.
According to the FDA, a biosimilar is approved based on a showing that it is highly similar to an FDA-approved biological medicine, known as a reference product, and has no clinically meaningful differences in terms of safety, purity and effectiveness from the reference product.
Biosimilars are approved by the FDA based on the totality of evidence and on extensive comparisons to the reference product, including detailed analytical and biological assays, followed by nonclinical and pharmacokinetic/pharmacodynamic studies and then confirmation in a clinical setting. In the European Union biosimilars have been approved for use since 2006. An analysis conducted by the Congressional Budget Office estimated that the introduction of biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion.1
Appropriate Coding for Biosimilars
Michael Werner, policy director with the Biosimilars Forum, submitted a public statement regarding the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting in May 2015.
The statement described the Forum, its mission and the benefits of biosimilars. “The introduction of biosimilars in the United States can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the healthcare system. Using state-of-the‐art technology and techniques, biosimilars are manufactured with the same excellence in standards as reference biologics,” he said.
Werner also noted that the Forum works on a consensus basis to develop policy positions to ensure the United States has a competitive, safe, and sustainable biosimilars market, providing more options to patients and physicians. “The goal of the forum is to promote a successful and sustainable biosimilar market in the United States that will provide options for patients and providers,” he said.
The group also made suggestions with regard to Biosimilar Medicare Part B Payment and Coding Policy. “The Biosimilars Forum strongly believes that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of biosimilars. Such a decision would not foster a sustainable or vibrant biosimilar market,” he said.
Citizen Petition
AbbVie recently filed a Citizen Petition with the FDA requesting clear and transparent product labeling of biosimilars to ensure patient safety.
The Biologics Price Competition and Innovation Act (BPCIA) deems biosimilars to be different from their originator products. Consequently, as biosimilars are introduced in the United States, there is potential for confusion about this new class of medicines, according to AbbVie.
AbbVie’s Citizen Petition requests that biosimilar product labeling clearly identify the product as a biosimilar and state that a biosimilar is not interchangeable with its originator (reference) biologic (unless FDA has deemed the biosimilar interchangeable).
According to the AbbVie Citizen Petition, applying the “same labeling” approach used for generic drugs to biosimilars may be misleading and could have serious implications for patient safety. The Citizen Petition also seeks to require that product labeling clearly distinguish between data derived from studies of the originator biologic and data derived from studies of the biosimilar.
A statement from AbbVie on the filing of the Citizen Petition emphasizes that labeling should also disclose the relevant data supporting the approval of the biosimilar and should distinguish these data from the data that were derived from the originator biologic. “Originator biologic medicines have extensive experience in the patient populations for the diseases the medicine is indicated to treat. It is critical that regulators work to ensure patient safety through rigorous review and clear product labeling of biosimilars as these medicines enter the US market,” according to the statement.
“Biosimilars are not generic drugs and should not be labeled like generic drugs. As biosimilars become available, there is confusion among patients and physicians about this new class of medicines, which threatens to compromise patient safety,” said Laura Schumacher, executive vice president, business development, external affairs and general counsel, AbbVie. “The requests in AbbVie’s petition are fundamentally about providing critical information about biosimilars to healthcare professionals.”
References
1. Congressional Budget Office; Cost Estimate of the Biologics Price Competition and Innovation Act, June 25, 2008.
A coalition of 11 companies involved in the development and manufacturing of biopharmaceuticals and “biosimilar” medicines recently formed the Biosimilars Forum, a nonprofit organization dedicated to expanding patient access to biosimilars in the United States.
The founding members of the Biosimilars Forum include Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. Many of these companies also provide branded biologic products, and together the Forum has extensive expertise and experience in the science, development, manufacturing, regulation and clinical applications of biological medicines. The Forum’s mission is to evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars, according to the founders.
The recently elected officers of the Biosimilars Forum are president, Juliana Reed, vice president, global government affairs, Hospira, Inc.; vice president, Hillel Cohen, PhD, executive director, scientific affairs, Sandoz Biopharmaceuticals (a Novartis company); treasurer, Geoffrey Eich, executive director, external affairs, Amgen Biosimilars; and secretary, Stacie Phan, director, state government affairs and public policy, Boehringer Ingelheim.
According to the FDA, a biosimilar is approved based on a showing that it is highly similar to an FDA-approved biological medicine, known as a reference product, and has no clinically meaningful differences in terms of safety, purity and effectiveness from the reference product.
Biosimilars are approved by the FDA based on the totality of evidence and on extensive comparisons to the reference product, including detailed analytical and biological assays, followed by nonclinical and pharmacokinetic/pharmacodynamic studies and then confirmation in a clinical setting. In the European Union biosimilars have been approved for use since 2006. An analysis conducted by the Congressional Budget Office estimated that the introduction of biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion.1
Appropriate Coding for Biosimilars
Michael Werner, policy director with the Biosimilars Forum, submitted a public statement regarding the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting in May 2015.
The statement described the Forum, its mission and the benefits of biosimilars. “The introduction of biosimilars in the United States can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the healthcare system. Using state-of-the‐art technology and techniques, biosimilars are manufactured with the same excellence in standards as reference biologics,” he said.
Werner also noted that the Forum works on a consensus basis to develop policy positions to ensure the United States has a competitive, safe, and sustainable biosimilars market, providing more options to patients and physicians. “The goal of the forum is to promote a successful and sustainable biosimilar market in the United States that will provide options for patients and providers,” he said.
The group also made suggestions with regard to Biosimilar Medicare Part B Payment and Coding Policy. “The Biosimilars Forum strongly believes that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of biosimilars. Such a decision would not foster a sustainable or vibrant biosimilar market,” he said.
Citizen Petition
AbbVie recently filed a Citizen Petition with the FDA requesting clear and transparent product labeling of biosimilars to ensure patient safety.
The Biologics Price Competition and Innovation Act (BPCIA) deems biosimilars to be different from their originator products. Consequently, as biosimilars are introduced in the United States, there is potential for confusion about this new class of medicines, according to AbbVie.
AbbVie’s Citizen Petition requests that biosimilar product labeling clearly identify the product as a biosimilar and state that a biosimilar is not interchangeable with its originator (reference) biologic (unless FDA has deemed the biosimilar interchangeable).
According to the AbbVie Citizen Petition, applying the “same labeling” approach used for generic drugs to biosimilars may be misleading and could have serious implications for patient safety. The Citizen Petition also seeks to require that product labeling clearly distinguish between data derived from studies of the originator biologic and data derived from studies of the biosimilar.
A statement from AbbVie on the filing of the Citizen Petition emphasizes that labeling should also disclose the relevant data supporting the approval of the biosimilar and should distinguish these data from the data that were derived from the originator biologic. “Originator biologic medicines have extensive experience in the patient populations for the diseases the medicine is indicated to treat. It is critical that regulators work to ensure patient safety through rigorous review and clear product labeling of biosimilars as these medicines enter the US market,” according to the statement.
“Biosimilars are not generic drugs and should not be labeled like generic drugs. As biosimilars become available, there is confusion among patients and physicians about this new class of medicines, which threatens to compromise patient safety,” said Laura Schumacher, executive vice president, business development, external affairs and general counsel, AbbVie. “The requests in AbbVie’s petition are fundamentally about providing critical information about biosimilars to healthcare professionals.”
References
1. Congressional Budget Office; Cost Estimate of the Biologics Price Competition and Innovation Act, June 25, 2008.
A coalition of 11 companies involved in the development and manufacturing of biopharmaceuticals and “biosimilar” medicines recently formed the Biosimilars Forum, a nonprofit organization dedicated to expanding patient access to biosimilars in the United States.
The founding members of the Biosimilars Forum include Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. Many of these companies also provide branded biologic products, and together the Forum has extensive expertise and experience in the science, development, manufacturing, regulation and clinical applications of biological medicines. The Forum’s mission is to evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars, according to the founders.
The recently elected officers of the Biosimilars Forum are president, Juliana Reed, vice president, global government affairs, Hospira, Inc.; vice president, Hillel Cohen, PhD, executive director, scientific affairs, Sandoz Biopharmaceuticals (a Novartis company); treasurer, Geoffrey Eich, executive director, external affairs, Amgen Biosimilars; and secretary, Stacie Phan, director, state government affairs and public policy, Boehringer Ingelheim.
According to the FDA, a biosimilar is approved based on a showing that it is highly similar to an FDA-approved biological medicine, known as a reference product, and has no clinically meaningful differences in terms of safety, purity and effectiveness from the reference product.
Biosimilars are approved by the FDA based on the totality of evidence and on extensive comparisons to the reference product, including detailed analytical and biological assays, followed by nonclinical and pharmacokinetic/pharmacodynamic studies and then confirmation in a clinical setting. In the European Union biosimilars have been approved for use since 2006. An analysis conducted by the Congressional Budget Office estimated that the introduction of biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion.1
Appropriate Coding for Biosimilars
Michael Werner, policy director with the Biosimilars Forum, submitted a public statement regarding the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting in May 2015.
The statement described the Forum, its mission and the benefits of biosimilars. “The introduction of biosimilars in the United States can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the healthcare system. Using state-of-the‐art technology and techniques, biosimilars are manufactured with the same excellence in standards as reference biologics,” he said.
Werner also noted that the Forum works on a consensus basis to develop policy positions to ensure the United States has a competitive, safe, and sustainable biosimilars market, providing more options to patients and physicians. “The goal of the forum is to promote a successful and sustainable biosimilar market in the United States that will provide options for patients and providers,” he said.
The group also made suggestions with regard to Biosimilar Medicare Part B Payment and Coding Policy. “The Biosimilars Forum strongly believes that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of biosimilars. Such a decision would not foster a sustainable or vibrant biosimilar market,” he said.
Citizen Petition
AbbVie recently filed a Citizen Petition with the FDA requesting clear and transparent product labeling of biosimilars to ensure patient safety.
The Biologics Price Competition and Innovation Act (BPCIA) deems biosimilars to be different from their originator products. Consequently, as biosimilars are introduced in the United States, there is potential for confusion about this new class of medicines, according to AbbVie.
AbbVie’s Citizen Petition requests that biosimilar product labeling clearly identify the product as a biosimilar and state that a biosimilar is not interchangeable with its originator (reference) biologic (unless FDA has deemed the biosimilar interchangeable).
According to the AbbVie Citizen Petition, applying the “same labeling” approach used for generic drugs to biosimilars may be misleading and could have serious implications for patient safety. The Citizen Petition also seeks to require that product labeling clearly distinguish between data derived from studies of the originator biologic and data derived from studies of the biosimilar.
A statement from AbbVie on the filing of the Citizen Petition emphasizes that labeling should also disclose the relevant data supporting the approval of the biosimilar and should distinguish these data from the data that were derived from the originator biologic. “Originator biologic medicines have extensive experience in the patient populations for the diseases the medicine is indicated to treat. It is critical that regulators work to ensure patient safety through rigorous review and clear product labeling of biosimilars as these medicines enter the US market,” according to the statement.
“Biosimilars are not generic drugs and should not be labeled like generic drugs. As biosimilars become available, there is confusion among patients and physicians about this new class of medicines, which threatens to compromise patient safety,” said Laura Schumacher, executive vice president, business development, external affairs and general counsel, AbbVie. “The requests in AbbVie’s petition are fundamentally about providing critical information about biosimilars to healthcare professionals.”
References
1. Congressional Budget Office; Cost Estimate of the Biologics Price Competition and Innovation Act, June 25, 2008.
