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Last Updated : Oct 12, 2018 05:33 PM IST | Source:

USFDA releases guidance to help generic drug makers copy complex ones

"These draft guidances are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," US FDA Commissioner Scott Gottlieb in a statement.

Viswanath Pilla @viswanath_pilla
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Viswanath Pilla
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As part of its efforts to promote generic competition and reduce healthcare costs, the USFDA has released guidance documents to advance the development of copycats for complex drugs.

This would help many Indian generic drug makers such as Sun Pharma, Dr Reddy’s, Lupin, Glenmark, Aurobindo Pharma, Cipla, Cadila Healthcare, Natco Pharma, among others in race to develop complex generics to beat the commodification of generics market.

Complex generics are drugs that, by nature of their formulation or delivery systems, are harder to copy under traditional approaches. As a result, these drugs often face less competition and are expensive.

"These draft guidances are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," US FDA Commissioner Scott Gottlieb in a statement.

The latest guidance is targeting transdermal patches and topical delivery systems to help generic drug makers with product-specific clarity enabling to design appropriate bio-equivalence (BE) and bioavailability (BA) studies in support of their abbreviated new drug applications (ANDAs) filings.

The 23 drugs for which guidance was issued included some top-selling patches for opioid dependence treatment drug Buprenorphine, Clonidine to treat high blood pressure, Diclofenac Epolamine for pain, and Estradiol or estrogen patch, among others.

"In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections," Gottleib said.

"We have made a new commitment to developing product-specific guidance documents laying out how to develop a generic copy of a branded medicine for any currently marketed, branded complex medicine in an effort to advance a more efficient and effective framework for developing generic copies of complex drugs," said Gottleib.

Gottlieb, who was appointed as Commissioner in May last year, has made lowering drug costs a top priority. Since then, the USFDA has been scaling approvals of generic drugs or low-cost copies of branded drugs to usher competition and drive down the price of medicines.

In 2017, USFDA approved/tentatively approved more than 1,000 generic drug applications, setting a record.

Gottlieb said the agency is on track for similar success in 2018. The agency also brought down the approval timeline from 3-5 years to 10 months.

In earlier times, when most drugs were small molecules requiring simple manufacturing processes. They were generally easy to characterise and evaluate through traditional methods, including traditional bioequivalence studies.

In most cases, a drug’s activity correlated directly with how quickly it got into the blood and how long the drug stayed in the blood, so it could have its intended effect on the intended site of action.

In contrast, complex drugs involve cases where the drug is often harder to formulate and manufacture because it has a complex formulation or complex active ingredient.

In other cases, the drug acts locally on the tissue rather than through the concentration in the blood. This includes inhaled drugs that act directly on the lungs, a topical patch that acts directly on the skin, or an eye drop that acts on the surface of the eye.

“The therapeutic effect of these types of drugs does not necessarily correlate with the amount in the blood and can be more difficult to measure through the blood. They can raise other issues that make the traditional, and often simpler, metrics generally used to evaluate generic drugs and prove sameness difficult to employ. There’s often no easy way to make the demonstrations necessary for generic approval,” Gottlieb said.
First Published on Oct 12, 2018 05:33 pm
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