A clinical trial is to compare a new treatment or drug to an existing one if one currently exists. Or the trial can be a new class of drug for which no prior treatment exists. A trial is conducted in three phases with phase III more closely resembling real-world conditions. Conducting trials are costly and time consuming to collect the required amount of data for biostatistical analysis to determine if the new drug offers significant improvement and is as safe or safer.

There may be other companies testing a biosimilar compound. A case in point is the drug Olaparib (Lynparza) made by Astra Zeneca and the biosimilar compound Rucaparib (Rubraca) by Clovis Oncology. Astra Zeneca had a significant head start and is a much larger, cash-rich Pharma company. Their head start led to generating the required data and submitting it to the FDA which led to approved use for a number of cancers including pancreatic.

Clovis was a new entry and a small bio pharmaceutical company. They were testing their compound on Ovarian and breast cancers when it was learned there was potential for treating pancreatic cancer in what is a very small cohort.

With a well established Pharma company already having 100% of the available cohort to sell their Rx drug, a smaller company with the same drug is faced with trying to use critical funds to get approval for ovarian and breast which is a larger cohort for fighting to gain market share.

Now imagine if you are the head of a small bio Pharma with limited funding. Do you dilute critical resources and try to go after a tiny population of pancreatic cancer patients with mutations that may respond to a PARP inhibitor and jeopardize getting the drug through the breast cancer trials so application can be made to the FDA where approval could mean gaining a market share of a bigger patient cohort? It sometimes comes down to a make or break decision and whether a company survives. Bottom line-there is an FDAapproved PARP inhibitor available and helping pancreatic cancer patients with targetable mutations now. Another fact is it takes about 13 years from the discovery of a bio active compound to receive FDA approval.

To get a drug through FDA approval is also very expensive. Every time filings of documents are made to the FDA, it is not a one-time fee that covers the submission. It costs millions of dollars to cover those filings.