World Biosimilar Congress Europe was held between 11-12 September in London, UK. Today, we would like to share some information with our readers who were not able to attend this interesting 2 days event.
The first speaker of the Day 1, Hideaki Nomura, who is the President and CEO of Fujifilm Kyowa Kirin Biologics Co., Ltd made a very detailed presentation about Japanese biologics market and his company. While mentioning the possible figures in 2016, Mr. Nomura shared the slide of IMS and said that, “(in the whole pharma sales) biologics will almost occupy top 10 products in 2016 (7 products)”.
Mr. Nomura gave some figures from Japan and said that satisfaction from therapies is increasing in years according to the Japanese data he presented. Japan is the most ageing society in the world and Japanese market has high drug prices said Mr. Nomura.
His company, Fujifilm Kyowa Kirin Biologics was established this year. Although Fujifilm was not a pharma company, they had strong background in high engineering technology and also the company is well known in consumer business. The first target of the new company is the biosimilar version of adalimumab, Abbott’s Humira.
The second presentation was from Abhijit Barve, President R&D of Biocon India. Mr. Barve started his presentation with some well-known data; according to IMS, 16% of global pharma expenditure was for biologics and this portion is growing faster than all other pharma sales. A biologics treatment can cost 45$ per day, although treatment with a small molecule can only cost 2-5$, Mr. Barve mentioned.
While mentioning about the US and EU markets, he stated that U.S. is still the largest pharma market in the world. Many biologics in Tier IV leading to higher co-payments and the concern from patients due to high out-of-pocket expenses increases in the United States. The situation is similar in the EU; many countries are now closely focusing at cost vs. benefit because lots of countries are facing huge financial challenges and drug price cuts are getting regular issues.
The Emerging Markets are large and still rapidly growing, Mr. Barve said. Government spending on healthcare is increasing and most of the countries are looking for value for money but the cost pressure is also increasing in Emerging Markets around the globe.
The conclusion of this presentation was: “Biosimilars will have an impact on lowering healthcare costs and improving access but when and how much is a multi-billion dollar question“.
The most intertesting presentation of the second day of the congress came from Mike Cohen, Managing Director of Myoderm. Myoderm is mainly focusing on supplying pharmaceutical products for clinical trials and Mr. Cohen gave lots of information about the supply problems of reference drugs for biosimilar clinical studies.
At the preclinical/analytical phase, small (10 or less) quantities and multiple lots (from 3 up to as many as possible) are needed Mr. Cohen said at the beginning of his presentation. For phase I studies, higher quantities are needed but less lots, he continued.
To supply phase 2-3 studies are the most critical issues: much larger quantities are needed and retention samples are required for each lot used, he said. Supply is not often available on the open market and in some cases it is only possible by providing manufacturer sponsor/trial information. Alternative strategy is to accumulate product from many lots which increases cost due to the number of retention samples and packaging runs needed, Mr. Cohen highlighted.
Some examples he mentioned were:
Roche/Genentech products: In the US, Genentech requires submission of sponsor and trial information and the company does not supply outside US. No CoA is available. But in the EU, the products are available on local country level and the CoAs are available.
Abbott products: Globally Abbott has a strict approval process and they often do not approve the supplies for study usage. In the US, it is not possible to get large volumes from single lots. In the EU, the situation is similar, it’s not possible to get more than 20-40 packs per month.
At the end of his presentation, Mr.Cohen added some points to consider before starting biosimilar development:
•In order to be successful in sourcing comparators for biosimilar trials, advanced planning is critical especially for larger volumes
•Research the markets carefully where you are conducting your trials
•Flexibility in lot requirements may help you with sourcing for larger trials
•Forward thinking is key as more later phase trials are conducted