March 15, 2013
On March 14, Dr. Dolinar gave a presentation on a “Clinicians’ Perspective on Biosimilars” at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings in Dallas.
View his presentation here.
March 12, 2013
ASBM Executive Director Michael Reilly was quoted in a BNA article on biosimilar state legislation.
Reproduced with permission from Pharmaceutical Law & Industry Report,11 PLIR 286 (March 1, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>
(BNA) — Will State Laws Thwart Use of Biosimilars?
Major Development: Several states are considering legislation that would require physician notification when a patient is switched from a branded biologic to an interchangeable biosimilar.
Brand, Generic Positions: Amgen, Genentech, and their allies are pushing for the state legislation. Meanwhile, generic companies say the state legislation is a “preemptive strike” by branded drug companies to limit access to these products.
Branded drug companies are pushing for state legislation that would place certain restrictions on biosimilars, while generic drug companies and pharmacy benefit managers say these proposals would limit patient access to these drugs and make them more expensive.
The 2010 health care reform law, through its Biologics Price Competition and Innovation Act (BPCIA), created a pathway for the Food and Drug Administration to approve follow-on biologic drugs, or biosimilars, but the agency still is working on implementation. The agency issued three draft guidances on biosimilars in 2012 (10 PLIR 173, 2/10/12) and has yet to issue guidance on the issue of interchangeability.
Brand biologic companies, including Amgen and Genentech, are pushing for state legislation on biosimilars that would require a physician to be notified when a pharmacist switches a patient from a brand biologic to an interchangeable biosimilar. Meanwhile, generic companies say state legislation should wait until after FDA is finished implementing the pathway so that legislation does not end up restricting access to these drugs.
According to the Generic Pharmaceutical Association (GPhA), bills are or have been under consideration in Arizona, Arkansas, Colorado, Florida, Indiana, Maryland, Massachusetts, Mississippi, North Dakota, Oregon, Pennsylvania, Texas, Virginia, and Washington.
Branded Company Campaign
Amgen Inc. said in a statement Jan. 25 that it is “helping to educate state policymakers” on biosimilars “to ensure that physicians, patients, and pharmacists share important information about biologic substitution.”
Amgen said physicians should be notified when a brand biologic is substituted with an interchangeable biosimilar. The company said it believes that a “notification process that does not impose an undue burden on the pharmacist is in the patient’s best interest.” The company said physician notification would “close the gap in biologic traceability that could otherwise be created.”
“Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level,” Scott Foraker, vice president and general manager of biosimilars at Amgen, said.
Amgen said state efforts to create safe substitution rules for interchangeable biologics will help accelerate the successful implementation of the U.S. biosimilars pathway.
Biologic medicines are different from traditional chemical drugs in several important ways, Amgen said. Biologics are so complex that they usually can only be made by a living cell. In fact, when made by different manufacturers, they differ from each other, the company said.
Biosimilars also have very large molecules compared to chemical drugs and can be more sensitive to storage and handling, Amgen said. As a result, biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine, the company said.
Amgen said it believes state pharmacy laws must enhance safety monitoring of substituted biologics.
Interchangeability
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.
ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include Amgen and Genentech.
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.
Opposition for State Legislation
Ralph Neas, president and chief executive officer of GPhA, told BNA that Amgen and Genentech are pushing for state legislation on biosimilars and are “engaged in preemptive strikes to limit access to safe, effective, and affordable biosimilars.”
Neas said if this effort is successful, it would decrease cost savings from these products and “it would have a destructive impact on many Americans,” as well as state budgets.
Amgen and Genentech are “raising questions” about these products and undermining trust in these new products, Neas said. These companies are “already trying to stack the deck in their favor.”
Neas said FDA still is implementing the biosimilars pathway and states could enact legislation after the pathway is created. He said that when FDA does approve an interchangeable biosimilar, patients and physicians should not have to deal with “roadblocks.”
“The more attention this issue receives, the more likely Genentech and Amgen’s efforts will fail,” Neas said.
“Biosimilars are not new and have been used in dozens of countries,” Neas said. “There are no reports of adverse events” in these countries and “the safety issue has been addressed already.”
“It’s up to FDA and not Amgen and Genentech,” Neas said.
On Feb. 6, GPhA praised Mississippi for voting down a bill that would make it more difficult for consumers to get access to biosimilar medicines. “With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state,” Neas said in a Feb. 6 statement.
Neas said that “if passed, these measures would be harmful [to] their constituents and wreak havoc on their state budget.”
“Like the American Cancer Society and others, we believe that the time to consider laws on biosimilars is after FDA has laid out a meaningful roadmap for the safety rules for these new medicines,” Neas said. “To do so before those regulations are released is a Trojan Horse: a measure to kill competition in the name of safety.”
FDA Commissioner Margaret A. Hamburg said at GPhA’s annual meeting Feb. 22 that “efforts to undermine trust in these [biosimilar] products is worrisome and represents a disservice to patients who could benefit from these lower cost treatments.”
“The high standard for approval of biosimilar and interchangeable products means that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy, and high quality that everyone expects and can count on,” Hamburg said.
PCMA Weighs In
The Pharmaceutical Care Management Association (PCMA) Jan. 31 said in a statement that the state proposals would increase costs for employers, public health programs, and patients, and restrict access to lower-cost alternatives. PCMA represents pharmacy benefit managers.
PCMA said the campaign by branded biologic manufacturers for these state proposals “is designed to preempt the FDA’s process by creating a flurry of state laws that will conflict with the FDA’s forthcoming national standards.”
“Creating a patchwork of dueling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar,” PCMA said. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs, the group said.
Mark Merritt, president and chief executive officer of PCMA, said “campaigning to restrict the use of biosimilars enriches brand manufacturers at the expense of the employers, public health programs, and patients who need access to lower cost medicines.”
The American Cancer Society Cancer Action Network (ACS CAN) said in a January statement that it is not taking a position yet on changing state pharmacy laws pertaining to the interchangeability, substitution, and related biosimilars patient protections until ‘we better understand the many complex regulatory and scientific issues as well as the current state of state pharmacy practice acts.”
ACS CAN said it “is very supportive of the advancement of both biologics and biosimilars because of their enormous potential as effective tools in the fight against cancer and the improvement of the quality of life for patients.”
By Bronwyn Mixter
The above story appeared in: Pharma. Law & Industry Report
March 12, 2013
ASBM Executive Director Michael Reilly was quoted in a BNA article on biosimilar state legislation.
Reproduced with permission from Pharmaceutical Law & Industry Report,11 PLIR 286 (March 1, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>
(BNA) — Will State Laws Thwart Use of Biosimilars?
Major Development: Several states are considering legislation that would require physician notification when a patient is switched from a branded biologic to an interchangeable biosimilar.
Brand, Generic Positions: Amgen, Genentech, and their allies are pushing for the state legislation. Meanwhile, generic companies say the state legislation is a “preemptive strike” by branded drug companies to limit access to these products.
Branded drug companies are pushing for state legislation that would place certain restrictions on biosimilars, while generic drug companies and pharmacy benefit managers say these proposals would limit patient access to these drugs and make them more expensive.
The 2010 health care reform law, through its Biologics Price Competition and Innovation Act (BPCIA), created a pathway for the Food and Drug Administration to approve follow-on biologic drugs, or biosimilars, but the agency still is working on implementation. The agency issued three draft guidances on biosimilars in 2012 (10 PLIR 173, 2/10/12) and has yet to issue guidance on the issue of interchangeability.
Brand biologic companies, including Amgen and Genentech, are pushing for state legislation on biosimilars that would require a physician to be notified when a pharmacist switches a patient from a brand biologic to an interchangeable biosimilar. Meanwhile, generic companies say state legislation should wait until after FDA is finished implementing the pathway so that legislation does not end up restricting access to these drugs.
According to the Generic Pharmaceutical Association (GPhA), bills are or have been under consideration in Arizona, Arkansas, Colorado, Florida, Indiana, Maryland, Massachusetts, Mississippi, North Dakota, Oregon, Pennsylvania, Texas, Virginia, and Washington.
Branded Company Campaign
Amgen Inc. said in a statement Jan. 25 that it is “helping to educate state policymakers” on biosimilars “to ensure that physicians, patients, and pharmacists share important information about biologic substitution.”
Amgen said physicians should be notified when a brand biologic is substituted with an interchangeable biosimilar. The company said it believes that a “notification process that does not impose an undue burden on the pharmacist is in the patient’s best interest.” The company said physician notification would “close the gap in biologic traceability that could otherwise be created.”
“Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level,” Scott Foraker, vice president and general manager of biosimilars at Amgen, said.
Amgen said state efforts to create safe substitution rules for interchangeable biologics will help accelerate the successful implementation of the U.S. biosimilars pathway.
Biologic medicines are different from traditional chemical drugs in several important ways, Amgen said. Biologics are so complex that they usually can only be made by a living cell. In fact, when made by different manufacturers, they differ from each other, the company said.
Biosimilars also have very large molecules compared to chemical drugs and can be more sensitive to storage and handling, Amgen said. As a result, biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine, the company said.
Amgen said it believes state pharmacy laws must enhance safety monitoring of substituted biologics.
Interchangeability
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.
ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include Amgen and Genentech.
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.
Opposition for State Legislation
Ralph Neas, president and chief executive officer of GPhA, told BNA that Amgen and Genentech are pushing for state legislation on biosimilars and are “engaged in preemptive strikes to limit access to safe, effective, and affordable biosimilars.”
Neas said if this effort is successful, it would decrease cost savings from these products and “it would have a destructive impact on many Americans,” as well as state budgets.
Amgen and Genentech are “raising questions” about these products and undermining trust in these new products, Neas said. These companies are “already trying to stack the deck in their favor.”
Neas said FDA still is implementing the biosimilars pathway and states could enact legislation after the pathway is created. He said that when FDA does approve an interchangeable biosimilar, patients and physicians should not have to deal with “roadblocks.”
“The more attention this issue receives, the more likely Genentech and Amgen’s efforts will fail,” Neas said.
“Biosimilars are not new and have been used in dozens of countries,” Neas said. “There are no reports of adverse events” in these countries and “the safety issue has been addressed already.”
“It’s up to FDA and not Amgen and Genentech,” Neas said.
On Feb. 6, GPhA praised Mississippi for voting down a bill that would make it more difficult for consumers to get access to biosimilar medicines. “With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state,” Neas said in a Feb. 6 statement.
Neas said that “if passed, these measures would be harmful [to] their constituents and wreak havoc on their state budget.”
“Like the American Cancer Society and others, we believe that the time to consider laws on biosimilars is after FDA has laid out a meaningful roadmap for the safety rules for these new medicines,” Neas said. “To do so before those regulations are released is a Trojan Horse: a measure to kill competition in the name of safety.”
FDA Commissioner Margaret A. Hamburg said at GPhA’s annual meeting Feb. 22 that “efforts to undermine trust in these [biosimilar] products is worrisome and represents a disservice to patients who could benefit from these lower cost treatments.”
“The high standard for approval of biosimilar and interchangeable products means that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy, and high quality that everyone expects and can count on,” Hamburg said.
PCMA Weighs In
The Pharmaceutical Care Management Association (PCMA) Jan. 31 said in a statement that the state proposals would increase costs for employers, public health programs, and patients, and restrict access to lower-cost alternatives. PCMA represents pharmacy benefit managers.
PCMA said the campaign by branded biologic manufacturers for these state proposals “is designed to preempt the FDA’s process by creating a flurry of state laws that will conflict with the FDA’s forthcoming national standards.”
“Creating a patchwork of dueling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar,” PCMA said. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs, the group said.
Mark Merritt, president and chief executive officer of PCMA, said “campaigning to restrict the use of biosimilars enriches brand manufacturers at the expense of the employers, public health programs, and patients who need access to lower cost medicines.”
The American Cancer Society Cancer Action Network (ACS CAN) said in a January statement that it is not taking a position yet on changing state pharmacy laws pertaining to the interchangeability, substitution, and related biosimilars patient protections until ‘we better understand the many complex regulatory and scientific issues as well as the current state of state pharmacy practice acts.”
ACS CAN said it “is very supportive of the advancement of both biologics and biosimilars because of their enormous potential as effective tools in the fight against cancer and the improvement of the quality of life for patients.”
By Bronwyn Mixter
The above story appeared in: Pharma. Law & Industry Report
March 7, 2013
WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) presented on March 5, 2013 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.
“Creating global standards for biosimilars has to boil down to one thing – patient safety – no matter where in the world the biosimilars are approved,” said Dr. Dolinar. “To safely bring biosimilars to patients, we should build on the science-based approach taken by the European Union (EU) and establish quality standards regarding the approval process, approach to naming, and substitution policies.”
“There is much to be learned from the great progress that has already begun in the EU, Canada and other countries. ASBM is committed to supporting the efforts of the U.S. Food and Drug Administration in their mission to safely bring biosimilars to the U.S., and helping develop and endorse standards that will bring effective biologic and biosimilar treatments to patients across the world.”
View Dr. Dolinar’s full presentation here.
Biologics are used to treat cancer, diabetes, MS, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.
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. Visit us at www.SafeBiologics.org.
March 7, 2013
Dr. Richard Dolinar presented at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C. on March 5.
Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines” stressed the need for a global regulatory environment that ensures patient safety, especially in regards to approval processes, biosimilar naming and substitution.
March 1, 2013
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following:
“The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway for the approval of biosimilars. For the past year FDA employees have been working tirelessly to establish the pathway that will make these breakthrough medicines available to patients in the U.S.
“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.’
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 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.
March 1, 2013
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following:
“The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway for the approval of biosimilars. For the past year FDA employees have been working tirelessly to establish the pathway that will make these breakthrough medicines available to patients in the U.S.
“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.’
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 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.
February 27, 2013
The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward.
Omontys was recalled following some fatal, severe allergic (anaphylactic) reactions that occurred within 30 minutes of receiving the first dose. Unless the problem can be traced to an obvious additive in the product or some characteristic in affected patients that made them susceptible to the reactions (enabling doctors to avoid dosing high risk patients) then quick re-introduction of the drug could be challenging.
In a statement, FDA said that there were 19 anaphylactic reaction reports. Three of these reactions resulted in death. Others required prompt medical intervention and resuscitation. Some required hospitalization. Omontys is used to treat anemia in kidney dialysis patients. It was supposed to compete directly with Amgen’s older and much more widely used drugs Epogen and Aranesp.
The episode could have broader implications for how FDA looks at biologics more generally, and especially other follow on products aimed at stimulating production of red blood cells. There is an inherent unpredictability in biologics owing to our inability to fully characterize these drugs. This truth is being borne in the relative caution that FDA has shown in fully implementing a pathway for the approval of “biosimilars” – follow on or generic versions of existing biologics. It will also affect how FDA views “bio betters” — new versions of existing drugs that are believed to have superior qualities that enhance the new drug’s safety or effectiveness.
This latest episode is likely to heighten FDA’s caution still more.
While Omontys was a different molecule than either Epogen or Aransep (and a fairly simple molecule) there could be some subtle, long-term lessons for FDA. The agency has years of experience with biological agents that simulate red blood cell production, and the inability to ferret out the risks with Omontys is likely to underscore how hard this science remains. Our tools for identifying both small and more significant differences between otherwise similar-acting biologics, and then translating when these changes can have clinical implications, are still an evolving science.
When these arguments were made during the debate over creating a biosimilars pathway, they were often dismissed. They were characterized as the self-interested pleadings of those trying to protect existing franchises. Perhaps there was some hyperbole on both sides of that debate. But the fact is, the science of biosimilar agents is still evolving. Regulatory constructs are likely to further reflect that evolving uncertainty.
For these reasons, FDA has already shown caution in approving “biosimilar” drugs and — in particular — defining a pathway for these medicines that gives sponsors a sufficiently easier route to the market than the one enjoyed by the innovator drug they are copying. This has created some uncertainty among sponsors whether the biosimilar pathway is really worth pursuing in certain cases, or would they be better off filing applications for new biologics (and securing the benefits that such a new Biologics License Application affords).
That environment of caution is likely to mount. It will blunt at least some of the economic rewards that policymakers envisioned when they created the biosimilars pathway.
The fact that the biosimilars don’t typically offer any clinical advantage (only potentially economic advantages) over their branded complements is likely to only increase the regulatory skittishness. The potential for risk needs to be weighed against the bounded public health benefits that these follow on products offer.
Episodes like these might also give added caution to physicians. Biologics that are seemingly similar in their structure and action can nonetheless have different profiles with important implications. Physicians could have additional pause about using the follow on drugs. All of these facts may weigh on the biosimilars enterprise.
As for FDA, it might well take a harder view that the safety of biosimiliars needs to be even more firmly established before approval. The same could apply to bio-better drugs that try and use new molecular scaffolding to achieve the same ends as existing biological drugs (especially tweaked versions that don’t offer distinct clinical advantages over the older medicines).
The situation involving Omontys is still unfolding, and many questions remain. But it is through episodes like these that FDA has often shaped some of its most cautionary principles.
February 27, 2013
With the start of a new year, comes the start of a new legislative calendar. The past weeks have been very busy as many states are considering substitution legislation. ASBM and our members have been sending in letters of support in CO, VA, IN and ND and will continue to express our concerns for patient safety as more legislation is introduced.
All state activity can be found on our “In the States” page on our website. You can also find our One Pager on Automatic Substitution stressing that patients and physicians want doctors involved in treatment decisions.
Colorado has been buzzing with the introduction of biosimilar substitution legislation House Bill 1121, which ASBM and our members have shown great support for. The CO bill was voted out of the House Health, Insurance & Environment Committee on February 12 and will be sent to the House and then the Senate for a full vote in the coming weeks. Thanks to Allen Todd with Global Healthy Living Foundation for testifying on behalf of patients before the committee.
Read his testimony here.
“If patients and their physicians do not know what medicines they are taking, they can’t make the right decisions; they deserve to know when a biologic that has been working to keep them alive is being substituted, especially until we learn more about biosimilars.
“We agree that when interchangeable biosimilar products are substituted, communication among patients, pharmacists, and health care providers is essential to patient care. Opponents of the bill suggest that its provisions are onerous and intended to prevent the substitution of biosimilars from occurring, however, the physician notification requirement does not kick in until after the substitution has occurred. Physicians and pharmacists work together on a daily basis to ensure patients receive proper care, and there is no reason why dealing with highly complex, next generation medicines should be any different.”
Read ASBM, GHLF and CCA’s letters here.
In Virginia, ASBM and several members sent letters of support for House Bill 1422. When the Senate version failed to adopt all of all patient protections that the House included in their bill ASBM, AfPA, CCA, GHLF, ICAN, Kidney Cancer and RetireSafe signed onto a joint letter with other patient groups urging the Senate to include provisions from the house bill.
The letter stated:
“For many of the more than two million Virginia patients—including our seniors, children and veterans—who suffer from one or more chronic illnesses, biologic medicines represent life-changing, and often lifesaving, therapies. They have improved quality of life, mitigated symptoms and reduced both disability and mortality rates.
“As important as these therapies are, it is just as important that public officials take special care to ensure the safety of the patients who rely upon them…That is why we strongly urge adoption by the Senate of all patient protections contained in House Bill 1422. This measure will bring Virginia state law in line with advances in modern medicine while also providing the essential safeguards that will ensure that Virginia patients receive exactly the medicines they need and will not be subject to potentially harmful substitutions.”
Read the full letter here.
Dr. Harry Gewanter, a pediatric rheumatologist in Richmond and member of the ASBM Advisory Board, penned an Op-Ed for the Richmond Times-Dispatch and also wrote a letter to the editor to the Lynchburg News & Advance in response to VA legislation.
In his Op-Ed “Legislation would protect patients taking complex meds,” he said:
“Specifically, the legislation would permit pharmacists to dispense a biosimilar that has been licensed by the FDA as substitutable with a prescribed biologic product, unless the patient’s doctor indicates otherwise or the patient asks for the brand-name version. It also would require the pharmacist to provide timely notification of this substitution to the doctor in a manner that is not a burden upon the pharmacist…Why is this important? We already know that each person responds differently to any medication, chemical or biologic. Generic chemical medications are easier to manufacture with less variability between them. However, since biologics and biosimilars are created using living cells, using current technology they can be closely approximated, but not necessarily exactly replicated. This creates a much greater chance of differences during the creation of a biologic and its biosimilar imitations. Any slight alteration in the production process could influence the effectiveness of a biologic and create unknown or negative consequences.”
Read the Op-Ed here.
In his letter “Healing or dollars?” Dr. Gewanter points out that the Senate version of the VA bill:
“Eliminates this critical communication between pharmacists, patients and their physicians in 2015. If I do not know that my patient with juvenile arthritis is not doing well because a substitution of a medication has occurred, I may change treatments or submit this child to many other evaluations that are not necessary. 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 [the Senate bill] touts.”
Read the full letter to the editor here.
We have also been following the bills in both Indiana and North Dakota and have sent in letters of support, highlighting the importance of allowing substitution as long as the biosimilar has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use and that the physician is notified.
Read the letters here.
Dr. Dolinar will be presenting at CBI’s 8th Biosimilars Summit, on the “Assess Global Quality Standards for Biologics in Regulated and Unregulated Markets” panel on March 5 in Washington, D.C.
Read more on the conference here.
