Zulushura Experiences related to biogenerics and regulatory guidelines in a regulated market are not as old as compared to conventional drugs. This is a likely consequence of the different cell lines. A study performed in Ontario showed that replacing Coumadin with generic warfarin was safe,  but many physicians are not comfortable with their patients taking branded generic equivalents. Generic drug Also, biogeneric companies will have biigeneric conduct costly clinical trials to prove safety and effectiveness. Also, it has been observed that market for resale of expired drugs with compromised safety and efficacy is mushrooming in India. The constitution of the biogeneric drugs can be either small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies.
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Salil Budhiraja, E-mail: ni. Sir, Biogenerics are biological products manufactured after expiry of the patent of innovator biopharmaceuticals. Biogenerics, also known as Biosimilars in Europe , Follow-on-biologics in the US , and subsequent entry 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. 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, etc , purification, 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 process 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. Recently, sibutramine, R-sibutramine and rosiglitazone were withdrawn from the Indian market based on foreign data. 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 be identical to that of the reference product is 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 biogenerics 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 chemical instability is caused by numerous chemical reactions and the physical instability by improper storage and handling factors.
In India, stability and storage specifications to be 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. References 1. The opportunity for India in the globale biosimilar market.
J Am Soc Nephrol. Dikshit RK. Challenges in Pharmacovigilance. Indian J Pharmacol. Nowicki M. Basic facts about pharmacovigilance. Kidney Blood Press Res. Ganesh K. Patient-doctor relationship: Changing perspectives and medical litigation. Indian J Urol. Hincal F.
U.S. Food and Drug Administration
Salil Budhiraja, E-mail: ni. Sir, Biogenerics are biological products manufactured after expiry of the patent of innovator biopharmaceuticals. Biogenerics, also known as Biosimilars in Europe , Follow-on-biologics in the US , and subsequent entry 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.
BIOGENERIC DRUGS PDF
See also: Drug nomenclature Generic drug names are constructed using standardized affixes that distinguish drugs between and within classes and suggest their action. Economics[ edit ] When a pharmaceutical company first markets a drug, it is usually under a patent that, until it expires, the company can use to exclude competitors by suing them for patent infringement. This profit often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable or do not pass clinical trials. Generics sold under license from the patent holder are known as authorized generics.
However, these products are not yet interchangeable with Herceptin, meaning if you -- or your healthplan -- want to use one of these biosimilars in place of Herceptin, a doctor will need to specifically order that biosimilar medication by name. The pharmacist cannot make the switch automatically at the pharmacy. In Phase III studies, researchers evaluated the safety, efficacy, and immunogenicity of Ixifi versus Remicade administered intravenously in combination with methotrexate to treat patients with moderate to severely active RA who have had an inadequate response to methotrexate therapy. Ixifi is not designated as interchangeable, unless specified by the prescriber. Retacrit , an erythropoiesis-stimulating agent ESA , was approved based on data showing that it is highly similar to Epogen and Procrit. It has no clinically meaningful differences in terms of safety, purity and potency when evaluated based on these drugs.