The Sri Lankan drug regulator, Cosmetics Devices and Drugs Regulatory Authority (CDDRA), has suspended registration of many biosimilar drugs of Dr Reddy's, Biocon, Wockhardt and Intas Biopharma with immediate effect.
The regulator said early this week that these companies have failed to furnish documents mandated by World Health Organisation. All of these players operate in Sri Lanka through local partners.
The products will be re-evaluated by the committee on similar bio- therapeutic products when the required documents are submitted, the regulator said.
The products affected include two drugs from Dr Reddy's stable, breast cancer drug Reditux and an anti-infective used in cancer patients, Grastim. Two of Biocon's drugs, head and neck cancer drug Biomab Egfr and cancer drug Nufil-Safe, have also been affected. Six of Wockhardt's drugs insulin Wosulin 30/70, Wosulin R, Wosulin N, cancer drug Wepox-30,000, Wepox 2000 and Wepox 4000 have been impacted. The Intas biopharma products, which have faced suspension of registration include Neukine, an anti-infective used for cancer patients, an immunological chemotherapy drug, Neupeg, and antiviral used in cancer patient, Intalfa.
This may not, however, have significant monetary impact on any of these companies, considering Sri Lanka in terms of size is not a major drug market for any of these players. When contacted a Biocon spokesperson said, "Biocon is aware about this communication to about 25 companies across the globe. We are developing biosimilars as per USFDA and EMEA guidelines, which are more stringent than WHO requirements. We have submitted the required information to the relevant authorities and we are expecting a favourable response very soon."
Emails seeking response on this issue sent on Friday morning to the other three companies elicited no response till the time of going to the press. A company official from one of these companies told FE on the condition of anonymity that the regulatory pathway for biosimilars is yet to be streamlined in both developed and developing markets and such lapses are part of the hiccups that pharma companies would face till such time regulatory pathways are strengthened. The drug regulator said, "The CDDRA has decided to suspend the registration of these similar bio-therapeutic products with immediate effect.
Additionally, the Sri Lankan drug regulator has pulled up many lesser known medical devices firms from India as their tested samples failed quality test. For instance, Nirma, better known for its FMCG products such as detergents, has been asked to withdraw two batches of disposable syringes. The drug regulator told the company's local partner, "You are totally responsible for consequences of use of this product after this notice; therefore, you must ensure that the product is withheld from use immediately, in the entire private sector.