Jan 13, 2018 10:54 AM IST | Source:

US FDA expediting of generic approvals a mixed bag for India drug makers

The US drug regulator has cleared record number of abbreviated new drug applications (ANDAs) in 2017, as it aims to expand competition in generic drugs and there by reduce healthcare costs for US citizens.

Viswanath Pilla @viswanath_pilla

The US drug regulator has cleared a record number of abbreviated new drug applications (ANDAs) in 2017, as it aims to expand competition in generic drugs and thereby reduce healthcare costs for US citizens.

US FDA approved 1027 generic drug approval in 2017 that includes 184 tentative approvals.  Tentative approvals do not allow the applicant to market the generic drug product until all patents exclusivity issues have expired.

"We recorded the highest annual total of generic drug approvals (1,027) in the agency’s history," said Scott Gottleib, Commissioner of US FDA in his blog.

"We believe that, if current trends continue, we’ll exceed this record number of generic drug approvals in 2018," Gottleib added.

US FDA achieved this by shortening the typical review period by streamlining and throwing more human resources. Earlier an approval averaged as long as 31 months.

US FDA in its Generic Drug User Fee Act (GDUFA) II guidelines released last year has committed for an average review cycle of just 10 months for approval.

To be sure, more approvals was also partly due to generic drug makers rushing to file ANDAs in 2017 - as US FDA increased the processing fee of generic applications from beginning this year. The agency raised processing fee by 143 percent to USD 1.71 lakh in 2018 citing high work load.

US President Donald Trump who promised to tackle sky-rocketing prescription drug prices in his election campaign couldn't take any visible action - as price controls is considered anathema to his conservative Republican Party.

Since Gottlieb took charge in May this year - the US FDA chief found a way around - by pushing the agency to approve more generic drugs and ensuring there is more competition. He also brought guidelines bringing more clarity on agency's expectations to approve complex drugs.

For large Indian generic drug makers such as Sun Pharma, Dr Reddy's, Lupin and Aurobindo more approvals means more competition and higher price erosion at time when just three buying groups control 90 percent of the channel distribution in US further pushing down the prices.

"Price decline in generics to continue in high single digits in 2018," said Lupin in a recent presentation.

"47 new generic manufacturers have entered the U.S. market in 2017 and

FDA approving more ANDAs but fewer approvals for new generics," Lupin said.

Lupin said to mitigate the price erosion in that market the company is resorting to portfolio optimization and cost efficiencies.

But more approvals means good news for companies looking for ramp up in US business.

Companies such as Laurus Labs, Strides Shasun, Granules India, Natco among others aspiring for piece of generic pie in US market were major gainers.

Laurus which is majorly into manufacture  of active pharmaceutical ingredients (APIs) or bulk drugs saw its maiden tentative approval from USFDA for Tenofovir Disoproxil Fumarate tablets 300mg used in treatment of HIV infection.

This tentative approval marks company’s foray into formulations business in US. The company has 8 ANDA filings in the pipeline.

Strides too had a busy year with launches of generic Lovaza and potassium citrate in the US market.

"We can't generalise faster approvals as good or bad," said Runjhun Jain, Senior Research Analyst at Nirmal Bang.

"It's going to benefit some and increase competition for others," Jain said.

Jain said 2018 will be busy year in terms of approvals.
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