Coordinated efforts are warranted to enable the availability of effective and affordable biologics and biosimilars, considering their promising prospects to treat cancer and other critical diseases.
‘Cancer’, merely overhearing or reading about this term manages to arouse some fear and loads of curiosity within us. Moreover, those who know about or deal with cancer patients can implicitly experience the physical and the mental distress associated with this condition, not to forget the enormous costs associated with its prolonged treatment schedules. Thus, globally, numerous researchers and technologists associated with oncology have been persistently engaged in developing strategies that will permit diagnosis of cancer at an early stage as well as developing better and economic therapies that may improve the survival rates in cancer patients.
These several efforts to manage cancer are undermined due to the huge costs and fatal side-effects associated with the conventional therapies. This has generated considerable interest and garnered sincere efforts towards the development of Targeted therapeutics, which may specifically target the cancer cells or tissues and hence result in fewer side-effects. These targeted therapies have been largely based on employment of small molecule drugs or macromolecules like monoclonal antibodies. The monoclonal antibodies are large and complex biologics, which as the name suggests are produced by living cells. In general, antibodies are like soldiers of our immune system which helps to protect our body cells from the attack of foreign invaders. With the advances in research and technology, scientists are able to produce monoclonal antibodies i.e. the antibodies specific for cancer or other disease related antigens. Although very effective, the production and purification of biologics is highly complicated and requires sophisticated instrument and skilled work force. Hence, they are very expensive and unaffordable for the patients belonging to the lower and middle income groups.
Nonetheless, an opportunity here lies in the expiry of patents filed by the innovator companies, which will enable other manufacturers to produce copies of biologics, using the similar processes. These copies are termed as Biosimilars, which greatly resemble the original generic drugs. Just like biologics, production of biosimilars is also carried out in living cells and hence precise replication of the large and complex biologics presents a huge challenge. However, regulatory authorities have placed stringent norms regarding the acceptable variations in biosimilars and are in the process of implementing strict protocols for monitoring their critical properties and qualities. Another aspect is the intense competition amongst those involved in manufacturing of biosimilars due to an open knowledge about the production processes of innovators, upon patent expiry. This may eventually reduce the cost of these therapeutics for critical diseases as cancer.
Thus coordinated efforts are warranted to enable the availability of effective and affordable biologics and biosimilars, considering their promising prospects to treat cancer and other critical diseases. Finally, but most importantly, as suggested by Dr.Nabhan from the National Institute of Cancer, USA, the first critical step towards adoption of biologics and biosimilars is the favourable perception of oncologists and clinicians towards these novel therapeutic molecules.
Edited By: Prajakta Dandekar Jain