ASBM Advisory Board Member Quoted in Inside Health Policy Article

March 15, 2013

On March 14, ASBM Advisory Board Member, Dr. Harry Gewanter was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up.” The article says:

“Harry Gewanter, a pediatric rheumatologist and Alliance for Safe Biologic Medicines board member, rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.

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

Read the full article here.


ASBM Advisory Board Member Quoted in Inside Health Policy Article

March 15, 2013

On March 14, ASBM Advisory Board Member, Dr. Harry Gewanter was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up.” The article says:

“Harry Gewanter, a pediatric rheumatologist and Alliance for Safe Biologic Medicines board member, rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.

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

Read the full article here.


Dr. Dolinar Presentation at Biosimilar Insulins Impact on Clinical Practice Meeting

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.


BNA: Branded, Generic Drugmakers Spar Over State Biosimilars Legislation

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


BNA: Branded, Generic Drugmakers Spar Over State Biosimilars Legislation

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


ASBM Chairman: Patient Safety Key to Creating Global Biosimilar Standards

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.


Dr. Dolinar Presents at CBI Conference

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.

 


Alliance for Safe Biologic Medicines Concerned Sequestration Cuts Could Delay Biosimilars Pathway

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.


Alliance for Safe Biologic Medicines Concerned Sequestration Cuts Could Delay Biosimilars Pathway

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.


Forbes: Blood Drug Woes Could Weigh on FDA and its Approval of New, Copycat Biologic Medicines

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.


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