Now that my first US biosimilars company is fully funded and has reached the commercial stage, I am launching another company, Karyo Biologics, operating in a partnering model, to overcome the physical limitations of every company (even if you are Amgen Pfizer  Sanofi Genzyme AbbVie Novartis Merck GSK Bristol-Myers Squibb Abbott Dr. Reddy’s Laboratories Biocon or Celltrion)in expanding its portfolio and in overcoming the inevitable delays due to the peculiar 351(k) regulatory expectations. 

I am thankful to dozens of major companies around the world who are now part of Karyo and most of all to FDA for giving us prompt responses to our submissions, stating that we are ready to file INDs. We are now the first private label US biosimilars company with a fast expanding portfolio and a proven fast-to-market opportunity for a broader category of distributors. Somehow I continue to believe that we can prove the value of BPCIA to make biosimilars more accessible (available and affordable), if we keep getting creative.