While this signifies continuing regulatory openness for biosimilars, the WHO‘s pilot program for prequalification of biosimilars comes as an added boost to the biosimilars industry. Created to provide greater access for essential drugs and API qualified by standard procedures to low and middle income countries (LMIC), WHO PQ program has established success in accelerating approval timelines, enhancing regulatory capacity and more importantly improving health outcomes and up-take of low cost generics in LMIC. In the pilot, WHO has proposed two pathways, one for biosimilars approved by stringent regulatory authorities (FDA, PMDA etc.) and the other pathway for drugs approved by other national regulatory authorities. This project will begin in October 2017, when WHO will publish it first expression of interest covering rituximab and trastuzumab. While the RoW markets have the highest need for biosimilars to expand healthcare access, we had highlighted in our White Paper that, level of penetration of biosimilars in RoW markets is very disappointing so far and RoI is elusive. The WHO PQ program is very promising as it holds the potential to expand markets in LMIC by introducing clinical confidence in product quality and use as a lower cost substitute to otherwise unaffordable biologics. After EMA and USFDA flagging in their approvals, WHO stepping in could imply that Era 3.0 for biosimilars is finally here.
It is also interesting to note that while Absorb had lukewarm sales in Europe and most global markets, it was popular in India and had a relatively larger share of the market. As a largely out-of-pocket market with limited participation of qualified payors in determining pricing, top quartile of patients of the otherwise price sensitive market have been easier and less discerning payors for expensive new medical technologies.
As Teva seeks to revitalize its operations under renewed leadership and divest its Women’s Health, Oncology and Pain management businesses, it has exited its intrauterine copper contraceptive product PARAGARD® to CooperSurgical for USD 1.1 billion. The company has decided to strengthen its strategic focus on its core business areas of CNS and respiratory, and is envisioning to use the proceedings to invest in a strong pipeline within these segments. Roche has become the second big pharma this month to streamline business focus, with their divesture of manufacturing facility to Swedish firm Recipharm AB. This deal comes as part of Roche’s restructuring strategy for its small molecule manufacturing in order to reinforce its newer generation therapeutics and more specialized manufacturing.
GST Impact on different Healthcare Sectors
Orthopedic Devices Market – At a Turning Point
Meet us at CPhI Worldwide 2017, Germany (October 24-26, 2017)
Meet us at JP Morgan Healthcare Conference, San Francisco (January 08-12, 2018)
MANDATES —ongoing assignments and partnering opportunities
- Buy side mandate – US generic opportunities
- Strategic investments – Leading Israeli CDMO with strong expertise in topical products
- Series A VC fund raising – Artificial Intelligence based digital health venture
- Business Plan – Medtech Translational Center, Specialty Veterinary Hospital
- Cold Chain Technologies: Transforming Food Supply Chains
- Embracing Innovation, Driving Growth Across Healthcare Continuum – “Making in India”
- The Make in India Imperative – Position Paper on Regulatory and Policy Changes required for Sustained Competitiveness of the Indian Vaccine Industry
- Indian Orthopedic Devices Market A $2.4 Bn Opportunity
- Biosimilars – How can we realize the $ 240 Bn Opportunity