The long-anticipated approval of the first biosimilar drug – a sort of generic biotechnology drug – occurred this morning. The FDA approved Sandoz’s version of. Introduction. Recombinant Therapeutic Proteins. Definition of Biogenerics. Regulatory Situation. Patent Situation. Biogeneric Targets: First. A generic drug is a pharmaceutical drug that has the same chemical substance as the drug that was originally developed, patented and innovated. Generic.
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Biogenerics are biological products manufactured after expiry of the patent of innovator biopharmaceuticals. Biogenerics, also known as Biosimilars in EuropeFollow-on-biologics in the USand subsequent bkogeneric biologicals in Japan are effective treatment for a number of serious and life-threatening illness because of their high specificity and activity.
India is growing in the arena of developing and marketing biogeneric products. Biogenerics are more complex compared to small molecule drugs.
Biogenerics: Are we ready to take safety challenges in India?
drugss Their quality and safety are highly dependent on the process of production choice of the cell type, development of the genetically modified cell for production, etcpurification, and formulation. Small changes can have significant effect on the safety and efficacy parameters of biogenerics as shown by a few instances in which manufacturing changes in the innovator biogeheric of biologicals have led to unforeseen adverse events.
For instance, more than expected cases of pure red cell aplasia were seen after administration of different formulations of epotein sold outside the US. Biogenerics are higher-rewarded but higher-risk products when compared to classic generic drugs. Experiences related to biogenerics and regulatory guidelines in a regulated market are not as old as compared to conventional drugs.
Currently, regulatory bodies insist on additional pharmacovigilance and risk management plans medication guide, patient package insert, communication plan to health care provider, special certified health care provider, pharmacies and healthcare settings for dispensing and prescription, certain monitoring of patients, enrolling patients in registry and timely assessment at 1.
Although safety information is collected in different phases of clinical research, because of constraints of limited exposure, time, non-inclusion of vulnerable population, etc, energetic and proactive plans are required for safety monitoring post marketing. India is still in infancy in the area of pharmacovigilance.
A well developed pharmacovigilance system is also lacking in most Indian pharmaceutical companies. Basic understanding about pharmacovigilance by healthcare professionals and consumers and motivation is almost negligible. Also, there is a scarcity of pharmacovigilance experts in India. For a product’s safety we rely on data from the other countries.
Recently, sibutramine, R-sibutramine and rosiglitazone were withdrawn from the Indian market based on foreign data. By definition, biogenerics will only be similar, but not identical, to the product they seek to replicate. When faced with the possibility of substituting an originator product with a biogeneric product, it is important to carefully consider the potential risks to the patient, such as that of an immunogenic response to a different molecule.
A classic example to illustrate that the safety profile of a biosimilar will not ddrugs identical to that of the reference product boigeneric the biosimilar growth hormone — Valtropine — that has different precautions and warnings than its reference product Humatrope.
This is a likely consequence of the different cell lines. Hence, physicians need to regularly update their knowledge for different safety concerns over bipgeneric and must closely supervise patients while switching over to these. In India, physicians are not able to spend quality time with patients, which results in a compromise on the safety concerns with an increased frequency of litigation against healthcare professionals and outcry in newspapers.
The effects of biogenerics depend on their structural integrity, and any factors causing physical and chemical instability alters the three-dimensional structure and folding pattern of proteins, which may lead to severe immunogenicity reactions. The chemical instability druge caused by numerous chemical reactions and the biogejeric instability by improper storage and handling factors. In India, stability and storage specifications to biogenerid followed for biogenerics may be a big challenge because of insufficient power supply and storage conditions.
Also, it has been observed that market for resale of expired drugs with compromised safety and efficacy is mushrooming in India. This may be a safety concern for biogenerics.
The biogenerics market is continuously growing in India at astronomical rate due to its important treatment options for a number of chronic and drug-resistant illnesses with their high specificity and activity.
As discussed earlier, this can lead to serious safety problems unless adequate care in the drug development and manufacturing is taken.
National Center for Biotechnology InformationU. Journal List Indian J Pharmacol v. Salil Budhiraja and Raghuram Akinapel.
Author information Copyright and License information Disclaimer. This is an open-access drubs distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3. Sir, Biogenerics are biological products manufactured after expiry of the patent of innovator biopharmaceuticals.
The opportunity for India in the globale biosimilar market. J Am Soc Nephrol. Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies.
BIO GENERIC DRUGS
Basic facts about pharmacovigilance. Kidney Blood Press Res. Changing perspectives and medical litigation.