CPhI 2018 Madrid: Pharma Market Vision /Biosimilar & Generics

Market forecasters remain optimistic about the opportunities for biosimilars and even though the shorter term outlook for generic medicines may be attenuated, the longer term is still positive. 
There are several factors that will influence the final situation.

• _Firstly there needs to be a policy change within the hospital environment to ensure that if a biosimilar wins the contract then there is a procedure in place to ensure that the biosimilar is used in practice. Some countries have introduced quota systems to make sure that biosimilar usage increases and this has worked to a degree. However, the ability of the originator to discount prices does lead to continued use of their products at the expense of the biosimilar. 


• _Further clarification on the right to substitute a biosimilar for the originator product is also required as in practice this does not seem to cause any issues but policies vary on this subject.

Generic medicines will remain under cost pressure and growth will have to be sought in new off-patent opportunities, even though these options may be less fruitful when compared to earlier years. All in all payers need generic medicines and biosimilars, the demand for lower and lower prices should not be allowed to threaten the sustainability of this vital part of the pharmaceutical industry.

Some companies are still hesitant to enter the biosimilar arena but with the advent of biological CDOs/CROs and CMOs there is the opportunity to minimise investments and still become a player. Returns will not be as high as the pure biosimilar play but the ability to have biosimilars within the portfolio will be important for some companies. 
On the generic medicine front the interest in added value generics continues. The major challenge here is obtaining an acceptable price for the medicine. Despite the benefits to patients (and also the cost of non-compliance), payers are reluctant to accept any premium over and above the vanilla generic product. 

Patient groups are on record in stating the issues around polypharmacy and the benefits from something as simple as a fixed dose combination medicine or modified release products. Added value is not just for patients, payers can benefit as well.

I believe that being first to market with a biosimilar will become more important in the future. Therefore a solid development programme and regulatory strategy will be essential. 
Biosimilar use in oncology will increase and open up access to many more patients than previously. Use of biosimilars in diseases of the immune system will drive awareness as their use in high volume primary care indications will position them closely alongside generic medicines. For generic medicines the respiratory device sector is still a challenge but once an acceptable device has been developed then the opportunity is significant.

CPhI Advisory Board member and renowned Pharma Expert, AlanSheppard, Managing Director of Ascher Resources shares insights into the year ahead for generics and biosimilars.
Alan has over 40 years extensive experience within the healthcare industry, including innovator R&D, generic and OTC companies and working with Government, law firms, venture capital companies and industry associations. 
Alan is responsible for developing services provided to the industry and its associations on generic medicines and biosimilars through consulting, information and market analyses.