Biosimilars: Are they generics?

Article contributed by Shaun Lee Chia Choon.

Shaun Lee is an aspiring clinical research professional with an interest in drug safety and development. He graduated with a Masters of Pharmacy qualification from The University of Bath UK and at the time of writing, is a study coordinator at Kuala Lumpur Hospital.


The short answer is no and here is why.

Generics are conventionally small-molecule drugs, commonly produced via synthetic methods. They are interchangeable with the reference innovator products as their approval depends on the fulfilment of regulatory requirements to be both bioequivalent (comparable pharmacokinetics) and pharmaceutically equivalent (identical active substance). In other words, generics are therapeutically equivalent carbon copies of the reference innovator products.

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Overview of the Medical Research & Ethics Committee’s (MREC) Industry Sponsored Research (ISR) Performance Statistics, 2014 – 2016

Gurpreet K*, Asha T*, Sharina MN*
*Medical Research Ethics Unit, NIH Secretariat, Ministry of Health Malaysia

MREC was formally established in 2002, with the purpose of safe guarding the rights, welfare and safety of subjects participating in research in Ministry of Health (MOH) facilities. It is the sole ethics committee for Ministry of Health facilities and may act as an Independent Ethics Committee for facilities outside the MOH.

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Investigator’s Corrective Action Plan Fails to Satisfy FDA

Following an FDA inspection, the agency lists identified deficiencies in a Form FDA 483, Inspectional Observations, and in the FDA Establishment Inspection Report. There is no regulatory requirement for the inspected party to respond to the Form FDA 483. Nevertheless, a well-reasoned, complete and timely response is generally in the inspected party’s best interests, not least because it may mitigate a decision for further action and demonstrates commitment and intent to comply, which will establish credibility with the FDA. When the inspected party chooses to provide a written response, any subsequent FDA warning letter is likely to include a judgement on the appropriateness of that response. From a review of even a small number of FDA warning letters, it is evident that the agency often finds that the corrective and preventive actions (CAPAs) proposed by inspected parties are inadequate. One such case is described below.

MISSED LABORATORY EVALUATIONS

An investigator participating in two oncology trials failed to perform a large number of protocol-required laboratory tests, including coagulation profile laboratory tests for four out of five subjects on up to 15 occasions. In addition he failed to perform liver function tests for all five subjects on at least three occasions. In his written response to these violations, the investigator confirmed that the protocol-required laboratory tests were missed for subjects enrolled in the two studies. He indicated that, as a part of his corrective action plan (CAP), he had added a “clinical trials link” to the site’s electronic medical record (EMR) to

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