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Speedy delivery: Bringing generics to market faster

BY Richard Monks

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

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Expediting the approval of new generics, the association and its members contended, will have a positive impact on patient care and help control the nation’s healthcare spending.

“GDUFA is a historic achievement for both the FDA and the generic pharmaceutical industry,” GPhA president and CEO Ralph Neas said last month as the FDA was preparing to hold a public hearing on moving GDUFA forward in fiscal 2015.

“Generic drug savings are a boon for patients, taxpayers, businesses, government and all who rely on access and choice when it comes to more affordable medicine,” he said. “In 2013 alone, generic drugs were responsible for $239 billion in savings for the U.S. health system.”

Noting that generic drug makers provide all of the funding for GDUFA — $300 million in 2013 — Neas and GPhA SVP regulatory affairs David Gaugh, who testified at the FDA hearing, said that for the program to be successful it must be implemented in a manner that reflects the realities of the marketplace and continues to provide incentives for the development of new generic medications.

“Since the implementation of GDUFA, all informal contact between reviewers and applicant has ceased and has not been replaced with any meaningful alternative. The result has been a major reduction in transparency,” Gaugh said.

 Enacted in 2012 as an extension of the FDA’s 20-year-old Prescription Drug User Fee Act, GDUFA is designed to get new generics on the market quicker, while also reducing drug makers’ expenditures. The law requires generic manufacturers to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. FDA officials said these added revenues eventually would enable the agency to reduce the backlog of pending new drug applications, cut the average time required to review generic drug applications for safety and increase risk-based inspections.

Despite its promise to speed up generic approvals, drug makers said that so far the law has had the opposite effect.

“Since the implementation of GDUFA, there have been some improvements, but in most areas GDUFA was designed to address — and especially in the timely handling of new drug applications — things are measurably worse than they were before the FDA began receiving hundreds of millions of dollars a year in new user fees,” John Ducker, president and CEO at generic drug maker Fresenius Kabi USA, told the FDA panel.

“Generic medicines have saved U.S. payers and patients about $1.5 trillion over the last 10 years. In the years ahead, savings like this will only be possible by more timely approval of generic medicines,” he said.

Where GDUFA has succeeded, GPhA and its member said, has been in prioritizing approvals of generic drugs that can provide the greatest public health benefits. For instance, Ducker said that in some cases, Fresenius Kabi’s products have been approved in a few weeks, enabling the company to help alleviate critical shortages.

However, he stressed, approval times for drugs that are not in short supply tell a different story.

Fresenius Kabi, for example, has more than 50 abbreviated new drug applications pending review. While the company has not targeted a date to bring these products to market, Ducker said he fears long delays because of the FDA’s plans to begin focusing on new submissions in order to meet what it said are obligatory performance metrics.

Proponents of generic drugs said that the key to making GDUFA work the way it was designed is to increase the lines of communication betweeen the FDA and drug makers. Regulators’ concerns, they stressed, can only be addressed when the drug companies are aware of them.

“GPhA believes a significant portion of the issues identified during the technical reviews can be classified as easily correctable deficiencies and communicated to applicants during the review process,” Gaugh said. “The industry is able to respond to ECDs in a short period of time — on the average, less than five days upon receipt of the ECD — which can facilitate the review process and enhance efficiencies for both the agency and industry.”

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FDA to review first biosimilar application

BY Jim Frederick

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

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The Food and Drug Administration defines biosimilars as products that mimic their original, already-approved biologically engineered counterpart, “notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity and potency.”

Thus far, that distinction has been academic within the U.S. pharmaceutical market, which has yet to see its first biosimilar approved for marketing by the FDA despite their common use in many other countries. But some four-and-a-half years after Congress and the White House enacted legislation calling on the agency to establish a review and approval pathway for biosimilars — and five years after passage of the Biologics Price Competition and Innovation Act of 2009 laying the groundwork for that approval process — there are signs that such a pathway is finally beginning to emerge.

In July, Novartis’ Sandoz unit became the first company to file for approval of a biologically engineered me-too pharmaceutical under the bio-similars pathway created by Congress and the Obama administration.

Sandoz announced that the FDA had accepted its biologics license application for filgrastim, a biosimilar modeled after Amgen’s Neupogen for the treatment of infection in patients receiving myelosup-pressive anticancer drugs. “The FDA’s acceptance of Sandoz’s filing is an important first step in increasing U.S. patient access to affordable, high-quality biologics,” the company noted in a statement.

Sandoz already markets filgrastim under the brand name ZARZIO in more than 40 countries outside the United States, according to the company. If approved by the FDA, the drug would be the first biosimilar available in the United States as early as 2015.

Meanwhile, investigational new drug applications for biosimilars continue to trickle into the FDA, with the agency receiving a total of eight INDs as of the end of June.

The Patient Protection and Affordable Care Act envisions what the FDA calls “an abbreviated licensure pathway for biological products that are demonstrated to be ‘biosimilar’ to or ‘interchangeable’ with an FDA-licensed biological product. But clearing that pathway for complex, biologically derived large-molecule compounds has been slow going. The agency, said FDA commissioner Dr. Margaret Hamburg, has labored to develop a review and approval process that sets “high standards for approval.”

“Building a new approval program of this complexity takes much time and deliberation, and that’s certainly been the case,” Hamburg said. “Congress deliberately set a very high bar for a biosimilar product approval. Manufacturers must demonstrate that their product is highly similar to, and differs in no clinically meaningful way, from the previously licensed product, known as the reference product, in terms of safety, purity and potency.”

Despite the slow, careful pace of progress at the FDA, the generic industry group predicts “a bright outlook for biosimilars,” with biologics amassing a total of some $60 billion in combined annual global revenues either already off patent or facing loss of patent protection over the next two years.

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WHO biosimilars naming proposal divides industries

BY Jim Frederick

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

Responding to requests from some countries’ regulatory agencies, the World Health Organization is mulling a proposal for a global identification system for biosimilar drugs that it says will help distinguish biosimilar and original biotech products, and avoid potential confusion among prescribing physicians and healthcare agencies. But the proposal is spawning debate among pioneer and generic drug companies worldwide, and opposing reactions from industry trade groups representing both sides of the debate.

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Specifically, the WHO’s new naming plan has raised concerns among companies that produce biosimilar medicines that their products could be elbowed out of the biotech market through neglect if they carry a different name than that of the original bio-engineered drug they’re designed to mimic. Industry groups like the Generic Pharmaceutical Association fear that creating distinct, separate names for biotech products and their biosimilar counterparts would confuse prescribing doctors and pharmacists, thus discouraging substitution of cheaper me-too biologic medicines and giving an unfair market advantage to branded biotech firms.

The issue revolves around the continued use of the same International Non-Proprietary Name for original, brand name biologics and their biosimilar counterparts. The WHO, which oversees that identification system, is proposing a nomenclature system that maintains the current practice by many developed countries of using the same INN to identify both the pioneer and follow-on biologic drug. But the global health group also is proposing the adoption of a secondary, voluntary identification code, dubbed a biological qualifier, to be attached to each drug to complement the INN identification system and “avoid proliferation of separate and distinct schemes developed by individual regulatory authorities.”

“This voluntary scheme is intended to provide a unique identification code (biological qualifier), distinct from the INN, for all biological substances that are assigned INNs,” the WHO noted in a statement. “The code will consist of four letters … assigned at random.”

Reaction was mixed, and generally broke along the divide between the pioneer biotech industry and biosimilars manufacturers and interest groups. The Biotechnology Industry Organization, representing branded biotech makers, endorsed the WHO proposal for the BQ identifier, “under which nonproprietary names of biological products that are similar to each other in structure and function are distinguishable,” noting that “distinguishable nonproprietary names enhance patient safety.”

The generic and biosimilars industries were less than enthusiastic, however. While supportive of the use of the INN for both biotech and biosimilar medications, they view the proposal for a second BQ marker as simply a tool that could be wielded by the biotech industry to head off competition from follow-on biologics.

“A biosimilar that is designed to be chemically and pharmacologically identical to the reference product should not have a different INN,” GPhA asserted. “Unique INNs … would divorce the biosimilar from its shared regulatory history with the reference originator product on which its approval is fundamentally based.”

GPhA concluded that a separate naming system would confuse prescribers, “thwart competition” and “make the collection of post-approval data and its analysis for adverse events … much more difficult.”

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G.MULLER says:
Oct-22-2014 11:25 pm

agreed

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