FDLI Annual Conference

April 26, 2013

On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations by CBER officials, Diane Maloney, Associate Director for Policy, and Mary Malarkey, director in the Office of Compliance and Biologics Quality, Michael led the panel discussion by giving brief remarks on the complex issues facing state legislators as they try to understand the differences between biosimilars and generics and why those differences have many physicians concerned if they are not informed by a pharmacist when a biosimilar is substituted for a prescribed biologic.

The panel was moderated by Scott Cunningham, a partner with Covington & Burling LLP and also included presentations from Brian Malkin, with Frommer, Lawrence & Haug LLP and Mark S. Robbins, PhD, with DiaMedica USA, Inc.

Read more here.

ASBM Executive Director Quoted in FDA News

April 17, 2013

ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King.

From FDA Draft Guidance Sets Rules for Biosimilar Meetings:

The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.

The document, which provides particulars on scheduling, preparing and conducting a formal meeting, appears to be an effort to “get the ball rolling” on a new process that many drugmakers are still struggling to comprehend, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines.

“I think that the applications aren’t rolling in yet because people are still trying to figure out what an application process is going to look like,” Reilly said. “Are you doing a BLA or a biosimilar application? That is a decision that manufacturers and investors have to make.”

Read the full article here.

ASBM Executive Director Quoted in FDA News

April 17, 2013

ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King.

From FDA Draft Guidance Sets Rules for Biosimilar Meetings:

The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.

The document, which provides particulars on scheduling, preparing and conducting a formal meeting, appears to be an effort to “get the ball rolling” on a new process that many drugmakers are still struggling to comprehend, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines.

“I think that the applications aren’t rolling in yet because people are still trying to figure out what an application process is going to look like,” Reilly said. “Are you doing a BLA or a biosimilar application? That is a decision that manufacturers and investors have to make.”

Read the full article here.

Sun Sentinel: Keep doctors informed and patients safe

April 4, 2013

ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel:

The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be treated? How will the disease progress? What are the health care options? Thanks to breakthroughs in the field of biotechnology, we are now able to offer them hope. Biotechnology has changed the game for neurologists. Several biologic medicines have been developed to reduce relapses of MS and slow down damage to the central nervous system, caused by the disease’s progression. Biologics are cutting-edge because they are manufactured with living cells, and they are able to specifically target the immune system in ways that chemical drugs cannot. Besides MS, biologics are also used to treat cancer, Parkinson’s disease, rheumatoid arthritis and autoimmune diseases.

In the laboratory, scientists manipulate living cells to grow these large, complex, genetically engineered molecules. A finished biologic product is thousands of times larger than a chemical drug like Ibuprofen. The complicated structure of these medicines makes them more susceptible to environmentalchanges and requires cautious handling by medical professionals.

To ensure safety of the patients taking biologic medicines, I lend my support, as a neurologist, to legislation working its way through the Florida Legislature, which will safely allow for the substitution of a new category of imitative biologic medicines, known as biosimilars.

House Bill 365 and Senate Bill 732 would help keep doctors aware of any substitutions made by pharmacists for interchangeable biosimilars. Physician notification is necessary to the success of my practice. Because of the unique characteristics of biologics and biosimilars, it is extremely important for me to know if a change had been made in my prescription. If a patient has an adverse reaction to a medicine, I would need to be able to identify the specific product that the patient received.

These bills provide the necessary safeguards to make biosimilars accessible for the residents of Florida and give specialists like myself the assurances they need to prescribe biologics at pharmacy counters.

Dr. Bruce S. Rubin is a board certified neurologist, voluntary assistant professor of Clinical Neurology at the University Of Miami Miller School of Medicine and director of the Spasticity Clinic at Jackson Memorial Hospital.

Sun Sentinel: Keep doctors informed and patients safe

April 4, 2013

ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel:

The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be treated? How will the disease progress? What are the health care options? Thanks to breakthroughs in the field of biotechnology, we are now able to offer them hope. Biotechnology has changed the game for neurologists. Several biologic medicines have been developed to reduce relapses of MS and slow down damage to the central nervous system, caused by the disease’s progression. Biologics are cutting-edge because they are manufactured with living cells, and they are able to specifically target the immune system in ways that chemical drugs cannot. Besides MS, biologics are also used to treat cancer, Parkinson’s disease, rheumatoid arthritis and autoimmune diseases.

In the laboratory, scientists manipulate living cells to grow these large, complex, genetically engineered molecules. A finished biologic product is thousands of times larger than a chemical drug like Ibuprofen. The complicated structure of these medicines makes them more susceptible to environmentalchanges and requires cautious handling by medical professionals.

To ensure safety of the patients taking biologic medicines, I lend my support, as a neurologist, to legislation working its way through the Florida Legislature, which will safely allow for the substitution of a new category of imitative biologic medicines, known as biosimilars.

House Bill 365 and Senate Bill 732 would help keep doctors aware of any substitutions made by pharmacists for interchangeable biosimilars. Physician notification is necessary to the success of my practice. Because of the unique characteristics of biologics and biosimilars, it is extremely important for me to know if a change had been made in my prescription. If a patient has an adverse reaction to a medicine, I would need to be able to identify the specific product that the patient received.

These bills provide the necessary safeguards to make biosimilars accessible for the residents of Florida and give specialists like myself the assurances they need to prescribe biologics at pharmacy counters.

Dr. Bruce S. Rubin is a board certified neurologist, voluntary assistant professor of Clinical Neurology at the University Of Miami Miller School of Medicine and director of the Spasticity Clinic at Jackson Memorial Hospital.

Indianapolis Business Journal LTE: Biologics misunderstood

April 2, 2013

In “Profits at center of biosimilars debate” [March 18], the author refers to attempted copies of biotech medicines as “generic biotech medicines.” This demonstrates a fundamental misunderstanding of biosimilars.

Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to understand why patient safety concerns are legitimate not only by drug companies, but by physicians who prescribe them.

As someone who treats patients whose health depends on access to biologics, it is troubling to me that the notion of alerting a patient that the medicine their physician prescribed them is being switched is onerous. There may be good reasons not to make a substitution, that a pharmacist may be unaware of, and it should be the physician’s role to help their patient make that decision.

Patients and their physicians deserve to know when a biologic that has been working to keep them alive is being substituted.

Dr. David Blank

Indianapolis Business Journal LTE: Biologics misunderstood

April 2, 2013

In “Profits at center of biosimilars debate” [March 18], the author refers to attempted copies of biotech medicines as “generic biotech medicines.” This demonstrates a fundamental misunderstanding of biosimilars.

Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to understand why patient safety concerns are legitimate not only by drug companies, but by physicians who prescribe them.

As someone who treats patients whose health depends on access to biologics, it is troubling to me that the notion of alerting a patient that the medicine their physician prescribed them is being switched is onerous. There may be good reasons not to make a substitution, that a pharmacist may be unaware of, and it should be the physician’s role to help their patient make that decision.

Patients and their physicians deserve to know when a biologic that has been working to keep them alive is being substituted.

Dr. David Blank

March 2013 Newsletter

March 27, 2013

State Activity

More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed bills focused on patient safety into law. Currently Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, Utah and Washington are considering legislation.

View our “In the States” page of the ASBM website to see letters of support and read the various bills.

ASBM Quoted in BNA Article on Substitution

ASBM Executive Director Michael Reilly talked to BNA reporter Bronwyn Mixter about biosimilar substitution state legislation.

“Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars. Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.

“‘If you look to Europe as a model,’ they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.

“Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. ‘Nobody knows what an interchangeable is,’ he said. ‘This is about when the first biosimilar is approved and how it is treated. There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,’ Reilly said.”

Read the article here.

HealthHIV Urges CO Legislators to Prioritize Patient Safety

On March 8, HealthHIV released a statement of support for Colorado Bill 1121 where Joseph Jefferson noted the three key reasons why:

“First, because of their unique nature and interaction with the immune system, it is essential that biosimilars be certified by the Food and Drug Administration as interchangeable with the original biologic.

“Second, prescribers must be notified of the substitution within a reasonable period of time. This is essential for patients managing HIV/AIDS who are often dealing with multiple medications and related chronic conditions. It is critical that the physician know exactly what treatment is administered to patients living with a compromised immune system.

“Finally, patients should be notified that the substitution has taken place, and HB 1121 allows for this. Patients living with HIV take a very active role in the management of their own health, and we believe it is their right to know exactly what treatment they have been given in order to monitor their body’s response, and then work closely with their physician and pharmacist, should they experience an adverse health event.”

Read the full statement here.

Dr. Gewanter Included in Inside Health Policy Article

ASBM Advisory Board Member, Dr. Harry Gewanter, was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up,” saying Dr. Gewanter:

“Rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.

“Chronic illness care requires close and ongoing communication between all members of a patient’s health care team. As a physician and a parent, I believe this communication and the resultant patient safety is far more important than any theoretical monetary savings Sen. (Steve) Newman (R) touts.”

Read more here.

Global Healthy Living Testifies at North Dakota Hearing

On March 11, GHLF’s Allen Todd provided testimony at the North Dakota House Human Services Committee where he stressed the need for treatments to be decided by patients and their physicians, and that pharmacists should notify the prescribing physician after a substitution has been made.

Read his testimony here.

Letter to WHO

In advance of the World Health Organization’s (WHO) 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances that will be held in April, ASBM sent a letter advocating that all biologics should receive distinct non-proprietary names.

Read the letter here.

Biosimilar Summit in D.C.

On March 5, Dr. Dolinar presented at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C.

Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines,” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.

View his presentation here.

ASBM Statement on Sequestration

Before the sequestration went into effect, ASBM released a statement expressing concerns that cuts could delay the biosimilars pathway.

In the statement, Dr. Dolinar said:

“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.”

Read the full statement here.

Biosimilar Insulins Impact Meeting in Dallas

Dr. Dolinar recently visited Dallas to give a “Clinicians’ Perspective on Biosimilars” presentation at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings.

View his presentation here.

March 2013 Newsletter

March 27, 2013

State Activity

More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed bills focused on patient safety into law. Currently Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, Utah and Washington are considering legislation.

View our “In the States” page of the ASBM website to see letters of support and read the various bills.

ASBM Quoted in BNA Article on Substitution

ASBM Executive Director Michael Reilly talked to BNA reporter Bronwyn Mixter about biosimilar substitution state legislation.

“Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars. Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.

“‘If you look to Europe as a model,’ they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.

“Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. ‘Nobody knows what an interchangeable is,’ he said. ‘This is about when the first biosimilar is approved and how it is treated. There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,’ Reilly said.”

Read the article here.

HealthHIV Urges CO Legislators to Prioritize Patient Safety

On March 8, HealthHIV released a statement of support for Colorado Bill 1121 where Joseph Jefferson noted the three key reasons why:

“First, because of their unique nature and interaction with the immune system, it is essential that biosimilars be certified by the Food and Drug Administration as interchangeable with the original biologic.

“Second, prescribers must be notified of the substitution within a reasonable period of time. This is essential for patients managing HIV/AIDS who are often dealing with multiple medications and related chronic conditions. It is critical that the physician know exactly what treatment is administered to patients living with a compromised immune system.

“Finally, patients should be notified that the substitution has taken place, and HB 1121 allows for this. Patients living with HIV take a very active role in the management of their own health, and we believe it is their right to know exactly what treatment they have been given in order to monitor their body’s response, and then work closely with their physician and pharmacist, should they experience an adverse health event.”

Read the full statement here.

Dr. Gewanter Included in Inside Health Policy Article

ASBM Advisory Board Member, Dr. Harry Gewanter, was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up,” saying Dr. Gewanter:

“Rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.

“Chronic illness care requires close and ongoing communication between all members of a patient’s health care team. As a physician and a parent, I believe this communication and the resultant patient safety is far more important than any theoretical monetary savings Sen. (Steve) Newman (R) touts.”

Read more here.

Global Healthy Living Testifies at North Dakota Hearing

On March 11, GHLF’s Allen Todd provided testimony at the North Dakota House Human Services Committee where he stressed the need for treatments to be decided by patients and their physicians, and that pharmacists should notify the prescribing physician after a substitution has been made.

Read his testimony here.

Letter to WHO

In advance of the World Health Organization’s (WHO) 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances that will be held in April, ASBM sent a letter advocating that all biologics should receive distinct non-proprietary names.

Read the letter here.

Biosimilar Summit in D.C.

On March 5, Dr. Dolinar presented at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C.

Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines,” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.

View his presentation here.

ASBM Statement on Sequestration

Before the sequestration went into effect, ASBM released a statement expressing concerns that cuts could delay the biosimilars pathway.

In the statement, Dr. Dolinar said:

“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.”

Read the full statement here.

Biosimilar Insulins Impact Meeting in Dallas

Dr. Dolinar recently visited Dallas to give a “Clinicians’ Perspective on Biosimilars” presentation at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings.

View his presentation here.

March 2013 Newsletter

March 27, 2013

State Activity

More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed bills focused on patient safety into law. Currently Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, Utah and Washington are considering legislation.

View our “In the States” page of the ASBM website to see letters of support and read the various bills.

ASBM Quoted in BNA Article on Substitution

ASBM Executive Director Michael Reilly talked to BNA reporter Bronwyn Mixter about biosimilar substitution state legislation.

“Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars. Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.

“‘If you look to Europe as a model,’ they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.

“Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. ‘Nobody knows what an interchangeable is,’ he said. ‘This is about when the first biosimilar is approved and how it is treated. There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,’ Reilly said.”

Read the article here.

HealthHIV Urges CO Legislators to Prioritize Patient Safety

On March 8, HealthHIV released a statement of support for Colorado Bill 1121 where Joseph Jefferson noted the three key reasons why:

“First, because of their unique nature and interaction with the immune system, it is essential that biosimilars be certified by the Food and Drug Administration as interchangeable with the original biologic.

“Second, prescribers must be notified of the substitution within a reasonable period of time. This is essential for patients managing HIV/AIDS who are often dealing with multiple medications and related chronic conditions. It is critical that the physician know exactly what treatment is administered to patients living with a compromised immune system.

“Finally, patients should be notified that the substitution has taken place, and HB 1121 allows for this. Patients living with HIV take a very active role in the management of their own health, and we believe it is their right to know exactly what treatment they have been given in order to monitor their body’s response, and then work closely with their physician and pharmacist, should they experience an adverse health event.”

Read the full statement here.

Dr. Gewanter Included in Inside Health Policy Article

ASBM Advisory Board Member, Dr. Harry Gewanter, was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up,” saying Dr. Gewanter:

“Rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.

“Chronic illness care requires close and ongoing communication between all members of a patient’s health care team. As a physician and a parent, I believe this communication and the resultant patient safety is far more important than any theoretical monetary savings Sen. (Steve) Newman (R) touts.”

Read more here.

Global Healthy Living Testifies at North Dakota Hearing

On March 11, GHLF’s Allen Todd provided testimony at the North Dakota House Human Services Committee where he stressed the need for treatments to be decided by patients and their physicians, and that pharmacists should notify the prescribing physician after a substitution has been made.

Read his testimony here.

Letter to WHO

In advance of the World Health Organization’s (WHO) 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances that will be held in April, ASBM sent a letter advocating that all biologics should receive distinct non-proprietary names.

Read the letter here.

Biosimilar Summit in D.C.

On March 5, Dr. Dolinar presented at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C.

Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines,” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.

View his presentation here.

ASBM Statement on Sequestration

Before the sequestration went into effect, ASBM released a statement expressing concerns that cuts could delay the biosimilars pathway.

In the statement, Dr. Dolinar said:

“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.”

Read the full statement here.

Biosimilar Insulins Impact Meeting in Dallas

Dr. Dolinar recently visited Dallas to give a “Clinicians’ Perspective on Biosimilars” presentation at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings.

View his presentation here.

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