The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive.

You’ve heard about them –  new kinds of medicine used to treat cancer, arthritis, multiple sclerosis, AIDS and other debilitating diseases – but you may not know that something very like them will be widely available soon and more affordable.  They’re called biologics and the oldest of them are coming off patent very soon.  So pharmaceutical companies all over the world have developed less expensive versions and want to hit the U.S. market as quickly as possible.

Government at both the federal and state level is grappling with the issue of how to substitute the expensive drugs with the newer versions while ensuring the substitutes work without causing harm.  The first issue was what to call them.  Cheaper versions of original drugs with inert ingredients are called generics, which means they are virtually identical to the original and work in exactly the same way.

But since no two living organisms are precisely alike, cells grown in one lab won’t be identical to cells grown in another.  So they can’t be accurately described as generic.  New versions are called bio-similars, or briefly bio-sims.  They’ll be considerably less expensive than the original meds because their manufacturers didn’t have to cover the costs of research.

Predictions are that patients could save as much as 30 percent of current costs. That’s a huge savings to insurers, including the State Health Plan, Medicaid, and Medicare. But since the bio-sims won’t be exactly like the original drugs, the results they produce may not be exactly alike either.  Even the most subtle differences in molecules can be important.

Assemblywoman Pamela Lampitt, D-Camden, believes both doctors and patients should be aware of exactly what they’re taking, so she’s introduced bill A2477 to spell out rules for dispensing and reporting. As with today’s generics, a physician could write “Do not substitute” on the prescription and the pharmacist must follow that instruction.

Otherwise, a pharmacist, using a list prepared by FDA, may substitute a bio-sim for the original medication but would have to print on the label the name of the dispensed product noting it is an interchangeable bio-sim, and within five days notify the prescribing physician the substitution was made. Pharmacy representatives don’t like the notification requirements.  Some say they would be too costly and time-consuming, while others believe they might lead patients to feel they’re getting an inferior product.

The bill’s co-sponsor, Assemblyman Herb Conaway, D- Burlington, who is a medical doctor and chair of the Assembly Health Committee, has held one hearing on the bill but no action was taken.  Sen. Joseph Vitale, D-Union, the Senate sponsor, is waiting for the Assembly to act before he jumps into the fray. Eight states have enacted similar laws recently.

The Washington-based Alliance for Safe Biologic Medicines strongly supports the bill’s requirement to notify physicians because they believe tracking and monitoring the use of bio-sims is essential to lessen risks and foster continuing improvements.  Lampitt says the FDA is likely to have bio-sims approved before the end of the year, so her goal is to have this legislation passed by June, allowing time for physicians and pharmacists to get ready.  Patients are ready now.

EDITOR’S NOTE: A former state assemblywoman from Jersey City, Joan Quigley is the president and CEO of the North Hudson Community Action Corp. in Union City. Her column appears in The Jersey Journal every Tuesday.


FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in San Diego, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in San Diego, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


NJ Spotlight: Legislature Grapples with How to Regulate Biologics, New Class of Medication

February 12, 2015

Measure would require pharmacists to inform doctors when they use new drugs, as well as generic ‘biosimilars’

Andrew Kitchenman

In recent years, many of the bestselling new medications haven’t been traditional drugs chemically synthesized in labs. Instead, they belong to a growing class of “biologics” — substances that are cultivated from living cells, often by altering the DNA that carries genetic information.

Biologics have been a boon to those with a variety of conditions, and are widely used to treat rheumatoid arthritis as well as to fight infections in chemotherapy patients. But these products often are expensive to develop and buy, racking up $66.3 billion in sales nationally in 2013. That’s why the 2010 Affordable Care Act included a provision to encourage the development of generic products that would be similar to but cheaper than the name-brand biologics.

New Jersey laws don’t cover how these so-called biosimilars should prescribed, which is why the Legislature is grappling with ways to regulate them. Biologics-industry representatives have supported state-level legislation addressing biosimilars prescriptions across the country. In fact, biosimilars aren’t yet available in the United States but could result in significant savings if the federal Food and Drug Administration approves.

Assemblywoman Pamela R. Lampitt (D-Burlington and Camden) noted estimates that biosimilars — which are currently sold in France, Canada, and other countries — could cut the cost of biologics by by 30 percent. That would translate into significant savings to the State Health Benefits Program.

Since state laws governing generic drugs don’t cover biosimilars, which are different from conventional drugs, Lampitt is working on legislation that would determine how pharmacies dispense this emerging class of medications. Without a new law, patients will only be able to receive lower-cost biosimilars if their doctor prescribers a biosimilar instead of a name-brand biologic.

Similar legislative efforts are ongoing in state legislatures across the country, as the FDA moves closer to approving biosimilars.

Lampitt noted that prescriptions for biologics should be treated differently than for traditional drugs, citing concerns over how subtle differences between name-brand biologics and biosimilars — and even between different batches of the same biologic — will affect patients.

She wants to require pharmacies to notify doctors every time they fill a prescription for a biologic, giving them a chance to respond if they have concerns about how the prescriptions are being filled.

Dr. Thomas Felix, research and development policy director for California-based Amgen, said his company is developing nine different biosimilars designed to compete with brand-name biologics whose patent protection is ending.

He said state-level legislation would ensure that doctors receive more information about biologic prescriptions than they currently do for traditional kinds of generic drugs.

Lampitt is working to revise the original version of a bill, A-2477 /S-1705, which currently would require pharmacists to directly inform patients when they substitute a biosimilar for a name-brand biologic. It’s expected to be amended so that the pharmacists would only have to notify doctors. Pharmacists would be required to notify doctors about all biologic prescriptions, not just when pharmacists substitute biosimilars.

John Holub, executive director of pharmacy trade group the New Jersey Council of Chain Drug Stores, said the industry would prefer that any new requirements for pharmacies be based on specific requests from doctors.

“This bill definitely deviates from the time-tested substitution laws,” Holub said, adding that the state could simply change current laws governing generic drugs to include biosimilars.

Holub also questioned the timing of the bill, saying that the FDA hasn’t even laid out its plans for how biosimilars will be regulated.

Sarah M. Adelman, vice president of insurance industry group the New Jersey Association of Health Plans, said insurers want to ensure that biosimilars are treated fairly and that patients aren’t wrongly led to fear that they are inferior to name-brand biologics.

The bill “should not limit, narrow or thwart the use of biosimilars in New Jersey by requiring notification; consent; reporting; or unnecessary barriers to access,” said Adelman.

Providing doctors with more information about biologics prescriptions drew support from groups that advocate for research and treatment of specific diseases.

Ethan Hasbrouck of the American Cancer Society Cancer Action Network said sharing more information with doctors about how prescriptions are filled would ensure that they have accurate records and contribute to patient safety.

“We’re very supportive of the advancement of both biologics and biosimilars because of their enormous potential as an effective tool in the fight against cancer and improving the quality of life of those cancer patients,” he said.

East Brunswick resident Christine Citera, who has psoriatic arthritis, said biologic medication has been essential in improving her quality of life.

“I’ve maintained my full-time job, I’ve hiked, I’ve gotten married — I was able to dance at my wedding,” she said. “Last year, I didn’t think that that was possible, and the biologic medication really allowed me to do this.”

But she said she’s had difficulty getting prescriptions filled and said it would be helpful to have legislation that made it clear what the responsibility of pharmacies are regarding biologics.

 


NJ Spotlight: Legislature Grapples with How to Regulate Biologics, New Class of Medication

February 12, 2015

Measure would require pharmacists to inform doctors when they use new drugs, as well as generic ‘biosimilars’

Andrew Kitchenman

In recent years, many of the bestselling new medications haven’t been traditional drugs chemically synthesized in labs. Instead, they belong to a growing class of “biologics” — substances that are cultivated from living cells, often by altering the DNA that carries genetic information.

Biologics have been a boon to those with a variety of conditions, and are widely used to treat rheumatoid arthritis as well as to fight infections in chemotherapy patients. But these products often are expensive to develop and buy, racking up $66.3 billion in sales nationally in 2013. That’s why the 2010 Affordable Care Act included a provision to encourage the development of generic products that would be similar to but cheaper than the name-brand biologics.

New Jersey laws don’t cover how these so-called biosimilars should prescribed, which is why the Legislature is grappling with ways to regulate them. Biologics-industry representatives have supported state-level legislation addressing biosimilars prescriptions across the country. In fact, biosimilars aren’t yet available in the United States but could result in significant savings if the federal Food and Drug Administration approves.

Assemblywoman Pamela R. Lampitt (D-Burlington and Camden) noted estimates that biosimilars — which are currently sold in France, Canada, and other countries — could cut the cost of biologics by by 30 percent. That would translate into significant savings to the State Health Benefits Program.

Since state laws governing generic drugs don’t cover biosimilars, which are different from conventional drugs, Lampitt is working on legislation that would determine how pharmacies dispense this emerging class of medications. Without a new law, patients will only be able to receive lower-cost biosimilars if their doctor prescribers a biosimilar instead of a name-brand biologic.

Similar legislative efforts are ongoing in state legislatures across the country, as the FDA moves closer to approving biosimilars.

Lampitt noted that prescriptions for biologics should be treated differently than for traditional drugs, citing concerns over how subtle differences between name-brand biologics and biosimilars — and even between different batches of the same biologic — will affect patients.

She wants to require pharmacies to notify doctors every time they fill a prescription for a biologic, giving them a chance to respond if they have concerns about how the prescriptions are being filled.

Dr. Thomas Felix, research and development policy director for California-based Amgen, said his company is developing nine different biosimilars designed to compete with brand-name biologics whose patent protection is ending.

He said state-level legislation would ensure that doctors receive more information about biologic prescriptions than they currently do for traditional kinds of generic drugs.

Lampitt is working to revise the original version of a bill, A-2477 /S-1705, which currently would require pharmacists to directly inform patients when they substitute a biosimilar for a name-brand biologic. It’s expected to be amended so that the pharmacists would only have to notify doctors. Pharmacists would be required to notify doctors about all biologic prescriptions, not just when pharmacists substitute biosimilars.

John Holub, executive director of pharmacy trade group the New Jersey Council of Chain Drug Stores, said the industry would prefer that any new requirements for pharmacies be based on specific requests from doctors.

“This bill definitely deviates from the time-tested substitution laws,” Holub said, adding that the state could simply change current laws governing generic drugs to include biosimilars.

Holub also questioned the timing of the bill, saying that the FDA hasn’t even laid out its plans for how biosimilars will be regulated.

Sarah M. Adelman, vice president of insurance industry group the New Jersey Association of Health Plans, said insurers want to ensure that biosimilars are treated fairly and that patients aren’t wrongly led to fear that they are inferior to name-brand biologics.

The bill “should not limit, narrow or thwart the use of biosimilars in New Jersey by requiring notification; consent; reporting; or unnecessary barriers to access,” said Adelman.

Providing doctors with more information about biologics prescriptions drew support from groups that advocate for research and treatment of specific diseases.

Ethan Hasbrouck of the American Cancer Society Cancer Action Network said sharing more information with doctors about how prescriptions are filled would ensure that they have accurate records and contribute to patient safety.

“We’re very supportive of the advancement of both biologics and biosimilars because of their enormous potential as an effective tool in the fight against cancer and improving the quality of life of those cancer patients,” he said.

East Brunswick resident Christine Citera, who has psoriatic arthritis, said biologic medication has been essential in improving her quality of life.

“I’ve maintained my full-time job, I’ve hiked, I’ve gotten married — I was able to dance at my wedding,” she said. “Last year, I didn’t think that that was possible, and the biologic medication really allowed me to do this.”

But she said she’s had difficulty getting prescriptions filled and said it would be helpful to have legislation that made it clear what the responsibility of pharmacies are regarding biologics.

 


January 2015 Newsletter

February 11, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

A few states where legislation is pending, include:

Colorado

On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

We are monitoring legislation in many other states and will provide updates as we have them.

Hamburg Steps Down

Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

ASBM Quoted in Inside Health Policy 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

Read the full article here.

New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.

ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair. 

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 

Read more here.

Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

 


February 2015 Newsletter

February 10, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

 

A few states where legislation is pending, include:

 

Colorado
On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

 

Georgia
SB 51
and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

 

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

 

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

 

We are monitoring legislation in many other states and will provide updates as we have them.

 

 


ASBM Quoted in Inside Health Policy 

 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

 

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

 

Read the full article here.

 

Hamburg Steps Down


Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

 


New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.


ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair.

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies” he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

 

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 


Read more here.

 

 


Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

February 2015 Newsletter

February 10, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

 

A few states where legislation is pending, include:

 

Colorado
On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

 

Georgia
SB 51
and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

 

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

 

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

 

We are monitoring legislation in many other states and will provide updates as we have them.

 

 


ASBM Quoted in Inside Health Policy 

 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

 

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

 

Read the full article here.

 

Hamburg Steps Down


Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

 


New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.


ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair.

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies” he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

 

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 


Read more here.

 

 


Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

Support for A2477 in NJ

February 4, 2015

On February 2, ASBM sent a letter to New Jersey Assemblywoman Pamela Lampitt supporting A2477, the bill she sponsored.

Read the letter here.


Support for A2477 in NJ

February 4, 2015

On February 2, ASBM sent a letter to New Jersey Assemblywoman Pamela Lampitt supporting A2477, the bill she sponsored.

Read the letter here.


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