Quality key for burgeoning US biosimilars market, says BIO panel
With the arrival of the first copycat biologic in the US last September, and with several others lining up to enter the market, it was no surprise that biosimilars were a key focus of this year’s BIO convention in San Francisco.
During a discussion about the future dynamics of this blossoming market, the question of biosimilar quality was approached and how manufacturing accountability needs to play a part in building confidence around these molecules.
“Whether it is a biosimilar or a branded medicine, these are all biologics. So not only at approval but throughout the lifecycle of the product we have to have a certain level of vigilance around quality,” said Amgen’s executive director for external affairs Geoffrey Eich.
“It’s important that manufacturers can be individually accountable for the quality of their product, and it is exactly right to create the right incentives to invest in quality of the product,” he continued.
“We want to avoid an ‘oops’ because an ‘oops’ of any kind is going to set back the efforts that all of us have put in for years to have a successful product.”
Darius Lakdawalla, Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the University of Southern California School of Pharmacy, agreed the level of regulatory scrutiny would keep quality high, and added the complexity of the manufacturing process should lead to significantly less quality variation in the biosimilars market than in the small molecules market.
Supply Chain Security
However, the cost to develop and make biosimilars will discourage competition, he continued.
While this will keep pricing discounts at a much lower rate than the typical 80% reduction seen with small molecule generics - Sandoz’s Zarxio was introduced in the US at a 15% discount on its reference product, Amgen’s Neupogen (filgrastim) for example – competition will be “valuable for other reasons than price.”
Having more players in the industry acts as an insurance against an ‘oops’ in production, Lakdawalla said.
“We’ve seen this in vaccines many times over that when you have a complex production process it is much more vulnerable to mishaps. If all of a sudden something goes wrong in a factory, we don’t have enough flu vaccine, for example.
“That could be a similar situation in biosimilars if we don’t encourage sufficient competition to ensure against supply chain breakdown.”
The original article had the headline: 'Quality issue could set back biosimilars in the US, says BIO panel.' While the panel discussion spoke about the prospect of a quality issue and its repercussions on the burgeoning biosimilar industry, Biopharma-Reporter feels the headline may have been alarmist of could have implied that there has been a problem with quality.