Chairing Panel Discussion with FDA at World Biosimilars World Congress

Pleased to be chairing the Biosimilars World Congress (23-24 May in San Diego, CA) panel discussion of the most important topic, “how to expedite approval of biosimilars.” I am delighted that the FDA has joined us, as well as several key stakeholders; sharing my years of developing biosimilars, this is going to be the most useful discussion for the developers, prescribers, payers and the regulatory agencies. Don’t miss this out.

I will be presenting the following topics:

Why is the bridging study needed in clinical trials when using multiple reference products?

If there no clinical meaningful difference, then why aren't biosimilars substituted?

Why is the industry so keen on conducting trials in patients, when the FDA is not?

How can the FDA and developers join hands to expedite approval of biosimilars?

What can the payers do to force entry of biosimilars to the US markets at reduced price?

I am sharing my first-hand experience in dealing with each of these topics, having taken several product through FDA and I believe that a sea of change is coming that will allow the BPCIA to provide the benefits anticipated for so long.

Speaking Engagements for Biosimilars

This is a busy year, as I will be presenting my newfound methodologies to take the biosimilars fast to market. I look forward to meeting my colleagues in the industry. I will be in Chicago, San Diego, Basel, China, India and Singapore, this year.

After decades of working on biosimilars, I have realized that there is a need to challenge the FDA with creative models for testing; this year I am introducing in vitro immunogenicity testing to obviate patient studies, eliminate all human trials for generic drugs and create a new pathway for substitutable biosimilars for naive patient, challenging the FDA finding that a biosimilar product has no clinically meaningful difference. I will be presenting results of my discussions with FDA.

FDA Suggests Filing IND for Insulin Glargine

Karyo Biologics' advanced program insulin glargine, eligible for filing under 505 B(2), has been reviewed by FDA in detail and the FDA has suggested that "we see no reason why karyo cannot file an IND." This is a great step for Karyo. The FDA has also allowed Karyo several concessions regarding the batch size and testing protocols, all intended to expedite the filing of IND. Karyo is also pleased to announce several major partnerships with CMOs and CROs in the US to help Karyo file its first IND soon. Once the IND is approved, Karyo will enter into licensing agreement with a commercial partner, making this the first-ever private label biosimilar offering in the USA. The cost of FDA approval has been finalized and comes to a record low compared to similar products approved recently. For more information please connect niazi@karyobio.com. Insulin glargine has hit $8+ Billion in 2017 and growing faster than Humira. Eli LIlly is the first holder of approved biosimilar insulin glargine.