RE:RE:RE:RE:RE:RE:RE:RE:Inflation Reduction Act (IRA) boosts biological drugs Chinese and Indian biomanufacturing executives recognize they lack capabilities required to participate globally.
In contrast to the successes in generic drug production, similar achievements for novel and biosimilar biotherapeutic products have yet to be realized due to a couple of major reasons: (i) these biotherapeutics, particularly monoclonal antibodies, are challenging to manufacture, are heterogeneous products, and require a high level of process control for a manufacturer to ensure consistent product quality and (ii) unlike generic drugs, whose price tags typically reflect a 90% reduction from their branded counterparts, a biosimilar is generally sold at a modest 20–30% reduction in cost relative to the innovator drug. One of the reasons for this limited pricing differential is that the manufacturing process for biosimilars and innovator products is more or less the same across the world and quite costly; (iii) the cost-of-goods for a biosimilar ranges from 30 to 50% of the product cost, compared to 5–10% for an innovator drug; (iv) Indian companies tend to stick with the same or similar manufacturing platforms as global innovator companies; and (v) there is reticence for change among Indian drug manufacturers for fear that radical modifications to their manufacturing technologies could increase regulatory risk, result in delays in regulatory approvals, and could even result in regulatory rejection. All these factors contribute to the lack of risk-taking in innovative manufacturing technologies of biotherapeutic products.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8617546/