ASBM Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16, 2015

CE Class Focuses on Fundamentals of Biosimilars

For Immediate Release:
March 16, 2015

EAST ELMHURST, NY – With the U.S. Food and Drug Administration’s (FDA) announcement of the first biosimilar approval, the Alliance for Safe Biologic Medicines (ASBM) held a five-hour class offered through the Long Island School of Pharmacy, to educate pharmacists on the fundamentals of these breakthrough new medicines. The continuing education (CE) class, “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,” was held at the New York LaGuardia Airport Marriott and explained what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them.

The class discussed the basic science and manufacturing of biologic medicines; the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs; their difference from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice; and the important regulatory and policy considerations – that many state capitals are currently legislating across the country.

Speakers throughout the day stressed the need to ensure patient safety and the importance of physicians and pharmacists working together to ensure that safety. ASBM Chairman and pediatric rheumatologist, Dr. Harry Gewanter and Global Colon Cancer Association Executive Director Andrew Spiegel provided a physician and patient perspective and Bruce Babbitt, PhD, Principal Consultant, PAREXEL Consulting gave a regulatory overview for the students taking the CE class. Ronald P. Jordan, BPharm, RPh, FAPhA, Dean, Chapman University School of Pharmacy spoke on the importance of the evolving role of pharmacists as biosimilars are approved.

“We are pleased to have ASBM come to New York and give a thorough overview of such an important class of medicines. This is especially timely, given that the FDA just approved the very first biosimilar for U.S. patients two weeks ago,” said Joseph J. Bova, M.S., R.PhI, Director of Continuing Professional Education, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, who gave opening remarks. “Biosimilars are highly advanced prescription medicines and it’s now more important than ever that we are educating the pharmacist community.”

In his presentation, Philip J. Schneider, M.S., F.A.S.H.P., Professor and Associate Dean for Academic and Professional Affairs, University of Arizona College of Pharmacy and ASBM International Advisory Board Chair, focused on the critical importance of communication and the need for physicians and pharmacists to work together. In his presentation, “Biosimilars: A Collaborative Approach to Pharmacovigilance,” he said that working in collaboration with physicians and notifying them if a patient receives a different medicine than what was prescribed, will create a stronger track and trace system where the medication’s efficacy can be assessed and proper attribution will be ensured in the case of an adverse event. He also stressed the importance of continued education for pharmacists, physicians and patients for these lifesaving medicines.

ASBM hopes this is the first of many forums to work with the pharmacist community to ensure patient safety.

Denver Business Journal: Biosimilars bill approved by Colorado Legislature

March 11, 2015

Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law.

The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk.

Read full story here.

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

March 9, 2015

 

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

For Immediate Release:
March 6, 2015

WASHINGTON – The Alliance for Safe Biologic Medicines today commended the U.S. Food and Drug Administration (FDA) on its approval of the first biosimilar to be available for sale in the U.S. market. Approval of Novartis’ Zarxio (filgrastim-sndz), biosimilar to Amgen’s Neupogen (filgrastim), was widely expected following the January recommendation by an FDA advisory panel that it be approved for all five indications for which the reference product is approved.

“The approval of the first biosimilar is a milestone for the agency and a significant positive development as patients and their physicians will have more treatment options,” said ASBM chairman Harry L Gewanter, MD. “We are particularly encouraged by the FDA’s recognition that a biosimilar is a different medication, distinct from its reference product, and that the distinguishable name given to this first biosimilar (filgrastim-sndz) allows healthcare providers to clearly differentiate it from the innovator medicine. The FDA is known around the world as a leader in patient safety, and distinguishable names are an affirmation of its commitment to transparency and accountability, and will make a difference in the safety of biologic medicines around the world. ASBM strongly encourages FDA to continue to use distinguishable naming for all future biosimilars it approves”, Gewanter added.

ASBM joined with more than 70 patient and physician groups in authoring a letter to FDA in August 2014 encouraging distinguishable naming of biosimilars. The FDA has stated, however, that the distinguishable naming of filgrastim-sndz should not interpreted as reflecting the agency’s support for a comprehensive policy of distinguishable naming for all biologics, including biosimilars. Such guidance on biosimilar naming is expected to be forthcoming shortly.

While “substantially similar” to the innovator product filgrastim, filgrastim-sndz has not yet received a designation of “interchangeable” by the FDA. Such a designation would indicate that switching between it and its reference product should produce the same effects in patients while posing no additional risks. Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which lays out the biosimilar approval process, only biosimilars designated “interchangeable” may be substituted by a pharmacist without physician involvement.

One area of concern, however, is in the labeling of Zarxio. “The labeling of Zarxio does not state that it is not interchangeable with its reference product, what data were supplied to earn approval is not specified, nor whether or not the product was studied in all the indications for which it was approved. If we are to ensure that biosimilars are to be accepted and successful, patients and physicians need clarity in both labeling and naming.” Gewanter said.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org

###

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

March 9, 2015

 

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

For Immediate Release:
March 6, 2015

WASHINGTON – The Alliance for Safe Biologic Medicines today commended the U.S. Food and Drug Administration (FDA) on its approval of the first biosimilar to be available for sale in the U.S. market. Approval of Novartis’ Zarxio (filgrastim-sndz), biosimilar to Amgen’s Neupogen (filgrastim), was widely expected following the January recommendation by an FDA advisory panel that it be approved for all five indications for which the reference product is approved.

“The approval of the first biosimilar is a milestone for the agency and a significant positive development as patients and their physicians will have more treatment options,” said ASBM chairman Harry L Gewanter, MD. “We are particularly encouraged by the FDA’s recognition that a biosimilar is a different medication, distinct from its reference product, and that the distinguishable name given to this first biosimilar (filgrastim-sndz) allows healthcare providers to clearly differentiate it from the innovator medicine. The FDA is known around the world as a leader in patient safety, and distinguishable names are an affirmation of its commitment to transparency and accountability, and will make a difference in the safety of biologic medicines around the world. ASBM strongly encourages FDA to continue to use distinguishable naming for all future biosimilars it approves”, Gewanter added.

ASBM joined with more than 70 patient and physician groups in authoring a letter to FDA in August 2014 encouraging distinguishable naming of biosimilars. The FDA has stated, however, that the distinguishable naming of filgrastim-sndz should not interpreted as reflecting the agency’s support for a comprehensive policy of distinguishable naming for all biologics, including biosimilars. Such guidance on biosimilar naming is expected to be forthcoming shortly.

While “substantially similar” to the innovator product filgrastim, filgrastim-sndz has not yet received a designation of “interchangeable” by the FDA. Such a designation would indicate that switching between it and its reference product should produce the same effects in patients while posing no additional risks. Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which lays out the biosimilar approval process, only biosimilars designated “interchangeable” may be substituted by a pharmacist without physician involvement.

One area of concern, however, is in the labeling of Zarxio. “The labeling of Zarxio does not state that it is not interchangeable with its reference product, what data were supplied to earn approval is not specified, nor whether or not the product was studied in all the indications for which it was approved. If we are to ensure that biosimilars are to be accepted and successful, patients and physicians need clarity in both labeling and naming.” Gewanter said.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org

###

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.

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.

 

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