Preclinical CRO Pushes into India to Reduce Human Bioequivalence Studies

The goal of the BCS and its introduction into India is to reduce the amount of time and money it takes generic companies to bring oral dosage treatments onto the US market by forgoing human bioequivalence testing through in vitro​ solubility, permeability and dissolution testing.

“Our testing takes about 4 weeks and is much cheaper than human [bioequivalence] testing​,” Patrick Dentinger, president and CEO of Absorption Systems, told Outsourcing-Pharma.com. The BCS system can eliminate some of the risk for generic companies introducing their generics into humans in trials.

The US FDA in 2000 established the pathway by which generic companies can forgo human testing through the three types of in vitro​ testing to obtain approval. Dentinger noted that India’s “rich generics space​” offers the company an opportunity to expand its business, which “has grown every year​” since the company was founded in 1996.

“The US FDA is really the only regulator that has fully embraced this idea​” of skipping human bioequivalence studies in some generic cases, though the WHO has endorsed it, Dentinger said. But he added that the company’s real challenge will be to encourage governments around the world to embrace this “less risky approach​,” especially in a country like India where the drug regulators are trying to keep pace with the innovation there.

Absorption Systems’ collaboration with Synerzys - a pharmaceutical consulting and advisory firm based in Mumbai, India – will begin with an attempt to educate potential clients on how the BCS works, Dentinger said, noting that Absorption Systems employees have been sent to India to speak at conferences and tradeshows in India beginning in May.

Although only about one-third of all oral treatments can use these series of tests to bypass human bioequivalence tests, Dentinger said he believes there is a robust group of Indian companies developing generics that could benefit from the BCS testing.

The system can also benefit formulators looking to develop better versions of a drug and expand its market, he noted, adding that BCS testing is also benefitting developers of new drugs.

South, Central America​

In addition to Absorption’s push intoIndia, the company established an office inPanamaand is targeting Central andSouth Americageneric markets.

“The benefit to a country like Argentina or India is that they don’t have to go through the learning curve as we’ve already done it​,” Dentinger said. “We’re spending a lot of time in Brazil, Argentina and Colombia​.”