Trastuzumab “can” be sold as a bio similar to Roche’s Trastuzumab

The division bench of the Delhi High Court, of Badar Durrez Ahmed and Sanjiv Sachdeva, has permitted Biocon and Mylan to use Roche’s product data for Trastuzumab. Roche had challenged the approval mechanism adopted by the central drug standards controller (CDSCO) in giving Biocon and Mylan approval for its biosimilar drug and their product inserts containing product data before the single judge.

 Earlier, the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.

 Stay tuned for a fuller report!


Trastuzumab cannot be sold as a bio similar to Roche’s Trastuzumab

In a recent decision, Justice Manmohan Singh of the Delhi High Court has restrained Biocon and Mylan to sell, manufacture, market and advertise their Trastuzumab as a bio similar to Roche’s Trastuzumab which is sold under the brand names of HERCEPTIN®, HERCLON™ and BICELTIS®.

Trastuzumab enjoys a global reputation for being an accepted biological treatment for HER 2 positive breast cancer worldwide. The facts of the case are as follows:

Roche Products is the importer and marketer of this innovator molecule in India. Biocon Limited co-developed and purported biosimilar version of Trastuzumab, along with Mylan Inc. and obtained an approval to market and sell the biosimilar version of Trastuzumab. Roche filed a suit for injunction against Biocon, Mylan Inc., and Mylan Pharmaceuticals Private Ltd. The Drug Controller General of India (DGCI) who granted the approval to Biocon and Mylan was also made a party to the suit.

Roche contended that the defendants’ drugs are, inter alia, being misrepresented as “Trastuzumab”, “biosimilar Trastuzumab” and a biosimilar version of HERCEPTIN® without following due process for obtaining appropriate approvals in accordance with the Guidelines on Similar Biologics. Roche also argued that Biocon has not conducted various tests required under the law for drug approval including  Phase I and Phase II trials. The defendant has also not independently generated requisite data in order to demonstrate similarity between the drug and the plaintiffs’ Trastuzumab, both in terms of the stages and the sample size of the tests conducted by defendant No.2.

It was also averred that as per the procedure for the approval of new drugs in India, after New Drugs Advisory Committee (NDAC) has reviewed an application for a new drug and given its recommendation, it refers such application to a Technical Committee (the “TC”), for consideration along with its recommendation. After the TC has endorsed the recommendation made by NDAC, it refers the application to the Apex Committee, and only after both TC and the Apex Committee have endorsed the recommendation of the NDAC, should defendant No.1 consider granting its approval to such an application.

This is usually a time consuming process and the consideration by the NDAC, the TC and the Apex Committee , but however this was done in a short span of five days i.e. between 18th October to 23rd October, 2013. The undue haste with which the approval was granted suggests that all factors relevant to the approval of a biosimilar drug under the Guidelines on Similar Biologies and under other internationally recognised standards were not taken into consideration at the time of granting such an approval.

The defendants argued that the application for manufacture of its drug was in conformance with the statutory requirements as contained in the relevant rules read with schedule Y of the Drugs & Cosmetics Act. under the said Act and corresponding Rules,  the term “Similar Biologics” has not been defined. However, the DCGI along with the Department of Bio -Technology had prepared “Guidelines on Similar Biologics: Regulatory Requirement for Marketing Authorization in India” in the year 2012. These guidelines are not statutory under the Drugs and Cosmetics Act and the Rules made thereunder. It was averred by the defendants that though the clinical trials of Phase I and Phase II have not been registered with the defendant No.1 but it did not skip Phase I trial as the main the objective of a Phase I trial is to establish comparative pharmacokinetics (pK) and this pK data was generated as the initial part of the Phase III trial. Defendant No.2 tried to give its justification for not doing the Phase II study as dose finding and POC studies are not required for follow-on products (biosimilars or generics).

Considering the overall facts and circumstances, Justice Manmohan Singh made the following prima-facie observations:-

–       the approvals as per existing protocol of biosimilar drug are contrary to the Rules, Guidelines of Biosimilar 2012 as well as directions issued by the Supreme Court.

–       the approvals which are in the hands of defendants are not in accordance with the protocol of biosimilar drug and guidelines, so far the defendant has not been able to satisfy before the Regulatory Authority as to whether the drug manufactured and marketed by the defendants is biosimilar.

As the final finding in this respect is yet to be arrived, the Court has given the following interim directions:

  1. a) The defendants may continue to manufacture, market and advertise their product under the name CANMAb or Bmab-200 or Hertraz on the basis of the approvals already granted without calling their product as “bio similar” and/ or “bio similar to HERCEPTIN, HERCLON, BICELTIS” or in any way ascribing any bio-similarity with that of the plaintiffs products HERCEPTIN, HERCLON, BICELTIS in any press releases, public announcements, promotional or other in printed form and from relying upon or referring the plaintiffs’ names.
  1. b) The defendants may also manufacture and market the drug by qualifying the INN name Trastuzumab but not to use the said name stand alone on the carton or package insert as a brand name. The defendants No.2 to 4 can use the INN name as Biocon’s Trastuzumab or Mylan’s Trastuzumab wherever applicable to describe the composition of molecule on the product as well as in its insert and not in a prominent manner. The said expression shall be used at the bottom part of the carton and should be in small size letters than their respective brand names.
  1. c) In view of prima facie findings that the use of the data by the defendants in the product insert without undergoing the entire process of the trials is misleading, the defendants are also restrained from using the data relating to manufacturing process, safety, efficacy and tests conducted for the safety of the drugs as complained of by the plaintiffs till the time the final decision on the issue of the bio similarity is made in the present suit.
  1. d) In the event, the defendant No.2 intends to claim bio similar as a description of its product or part of its promotional campaign or otherwise in any other form, the defendant No.2, if so advised, can re-apply the said license before the relevant authorities including defendant no. 1 and in which case, the defendant No.1, the authorities and committees framed therein shall decide the said approval application in accordance with the Rules and Guidelines of 2012 and also the observations made by this court in the present order. In the alternative, the defendant No.2 may await the outcome of the present suit and can continue with the present arrangement as an interim measure.
  1. e) This interim measure is made only in view of the peculiar facts in the present case wherein the defendant No.2 is already in possession of approvals granted rightly or wrongly validity of which is questioned in this suit. All the decisions made by the DCGI and authorities and committees made therein in connection with future approvals shall take into consideration the guidelines of 2012 and also the findings arrived at in the present order by this court.


Central Drugs Standard Control Organization (CDSCO) has notified draft guidelines for biosimilar developers. The guidelines lay down a regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic. The CDSCO has invited suggestions and /or comments of the stakeholders by 30th April, 2016.

We shall upload a digest of these guidelines, especially on how they vary from the existing 2012 guidelines. Stay tuned for more updates on this section.