Diem Nguyen, head of Pfizer's biosimilars unit, says it is only a matter of time before biosimilars become more prevalent in the marketing including the US. She says it's still early in the US and as some of the bigger monoclonal antibodies start coming off patent more biosimilars will start appearing. This should be significant by a 2015 time frame.
Pfizer is investing in both novel biologics and in biosimilars. It sees the latter as less risky due to known safety and efficacy of these molecules. They acknowledge programs to create biosimilar versions of Rituxan, Herceptin and Remicade. They also have at least two other programs in operation that have not yet been divulged but will be soon. Pfizer is focused in the oncology and inflammation/rheumatology area where the big mAb biologicals reside that are nearing patent expiration.
Pfizer says that it too ascribes to the industry dogma that biosimilars will be about 20-30% cheaper than their innovator counterpart. I would bet the price depression will be more than that -- especially in emerging countries. I also think there will be more pressure to make these interchangeable as governments look to stem costs. Pfizer seems content to let the FDA make this call in the US. Outside the US, some countries, e.g. India, already approve biosimilars that may not be approvable as such in the EU or US.
Nguyen says Pfizer will take an integrated commercial and R&D approach to developing biosimilars that have attributes attractive to physicians and patients. She views biosimilars as hybrids of generic and innovator medicines. See Pharmalot.
Posted by Bruce Lehr Sep 12 2013.