One of the critical measures for the potential success of any new drug is how quickly specialists will start prescribing them. So analysts for Decision Resources turned to several groups to check their eagerness to lay their hands on a new generation of biosimilars. And they found a high level of wariness for any follow-on that isn't backed by a convincing set of data on exactly the ailment they're treating.
In their new analysis, the consultancy group queried rheumatologists, nephrologists and gastroenterologists about "indication extrapolation," using the data from one study to influence them on how they might use a biosimilar for a separate indication. But with even minute differences between biosimilars and branded drugs often accounting for big differences in efficacy, Decision Resources found that doctors in Europe as well as the U.S. weren't keen on the notion.
For developers, their response underscores an oft-repeated assumption about these new drugs. Regulators and physicians, particularly in the U.S., are going to demand detailed data before these biosimilars can gain any market ground. And that will push the cost of development up high, where only the biggest companies can afford to compete.
"It's not surprising to see that rheumatologists, nephrologists and gastroenterologists we surveyed are wary of indication extrapolation as these specialists have expressed a moderately conservative approach to biosimilars," said Decision Resources analyst Edward Wydysh. "To meet physician expectations, biosimilar manufacturers will most likely need to conduct clinical trials in several indications, which may be cost-prohibitive for a smaller company to enter the market. If a biosimilar manufacturer with fewer resources wants to compete with an original biologic in more indications, it should focus on therapeutic areas and drug classes that surveyed physicians find most acceptable for extrapolation, for instance granulocyte colony stimulating factors, or G-CSFs, in oncology."
- check out the Decision Resources release