Blogs

China’s Food and Drug Administration has started implementing key reforms that are likely to be a game changer for pharma companies eyeing the Chinese market.  The presentation below highlights the key reforms:     Key Takeaways: Leveling of Phase 1 playing field: Pharma companies can run a phase 1 trial in china simultaneously as they run Phase 1 trial outside of China Multi Regional Clinical Trials are acceptable – CFDA would also allow foreign companies to

A biosimilar product is essentially a non-inferior ‘twin’ of the reference biologic with similar clinical efficacy and safety. Biosimilar development is a fairly new and evolving landscape with many unique operational challenges. This blog explores some of these challenges and ways to overcome the barriers. The regulatory approval requires biosimilar developers to establish similarity of the potential biosimilar to its reference biologic. The direct comparative analysis requires a biosimilar developer to create a quality target

Finally, FDA has come out with its interchangeability guidelines.  The US drug regulatory agency has presented its recommendations for the data requirement for a biologic product to be interchangeable to a reference product. You may go through the draft guidance upon following the link. As per the FDA guidelines, an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product, leading to

The Oncologic Drugs Advisory Committee (ODAC) of FDA has unanimously recommended approval of subcutaneous (SC) rituximab for the treatment of patients with certain blood cancers. A final approval to this effect is expected by June 26, 2017 (Official Announcement). The approval of SC formulation certainly has its benefits such as, reduced drug delivery time – as opposed to an hour and half or more needed to administer IV formulation, the SC formulation could be delivered

Commercialization is the next frontier for biosimilar developers. As more and more biosimilars are gaining regulatory approvals, the discussion on commercial aspects of the yet evolving market is gaining momentum. Biosimilar commercialization will have its very specific attributes and nuances. Biosimilars are neither first- nor best- in class products, these are categorically “similar” products which are “me too” in terms of safety and efficacy. The innovators and big pharma players, used to product/brand marketing, will

65 big/small/medium Pharmaceutical companies and 10 publishers took part in the ESMO. A white based theme was observed for all the booths in the ESMO Exhibition area. The booths attracted a lot of footfall and were packed right from day 1 of the conference.  Most of the companies of our interest stayed away from promotional messages and emotive imagery and chose to restrict booth messaging to trial readouts and known facts about their products. Of