send mail to support@abhimanu.com mentioning your email id and mobileno registered with us! if details not recieved
Resend Opt after 60 Sec.
By Loging in you agree to Terms of Services and Privacy Policy
Please specify
Please verify your mobile number
Login not allowed, Please logout from existing browser
Please update your name
Subscribe to Notifications
Stay updated with the latest Current affairs and other important updates regarding video Lectures, Test Schedules, live sessions etc..
Your Free user account at abhipedia has been created.
Remember, success is a journey, not a destination. Stay motivated and keep moving forward!
Refer & Earn
Enquire Now
My Abhipedia Earning
Kindly Login to view your earning
Support
Biotechnology derived medicinal products are presently the best characterized biologics with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologics is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product.
Key Concerns Safety is a priority for the development of all medicines, but biologics raise safety considerations above and beyond those of chemical drugs. This is because biologics are more structurally complex medicines than chemical drugs, and even slight changes in their manufacture can cause undetected changes in the biological composition of the product. These changes can in turn affect the safety and effectiveness of the product in patients.
Biologics are made by genetically engineering living cells to become miniature factories producing the desired molecules (proteins). These living cells are inherently variable and susceptible to slight changes in their environment that can significantly alter the proteins they are engineered to produce. Because no two living cell lines are identical, no two biologics manufacturing processes have identical starting materials or proceed in the same way. A follow-on biologic manufacturer that uses different starting materials and a different process will produce a product that is different from the innovative product. In addition, the complexity of biologics currently makes it impossible to show in the laboratory that one biological product will work the same as another in patients. The effects of the differences between a follow-on and its respective innovator product can only be determined by subjecting the follow-on biologic to substantial clinical testing in patients to prove that it is safe and effective. Therefore it is not possible to have a "generic" of a branded biologic.
Biologics are expensive to produce and costly for payers and many patients, depending on their insurance coverage.
Immunogenicity is an important concern regarding the safety of biologics. This occurs when our bodies treat a protein as if it is a foreign substance and try to attack the protein with antibodies. Unlike chemical drugs, all biologics have the potential to stimulate antibody production in patients and such responses are highly unpredictable. Sometimes the antibodies produced in response to a biologic have no effect. Other times they bind and inactivate the biologic, causing disease progression. In still other cases, they can bind to and inactivate a patient's naturally occurring protein, which means that the patient may be left with no options other than regular blood transfusions.
Biopharmaceuticals are drug products containing biotechnology-derived proteins as active substances, and have revolutionised the treatment of many diseases. A number of biopharmaceutical patents are due to expire in the next few years, or have already expired. The subsequent production of follow-on products, or 'biosimilars' has aroused interest within the pharmaceutical industry as biosimilar manufacturers strive to obtain part of an already large and rapidly-growing market. The potential opportunity for price reductions versus the originator biopharmaceuticals remains to be determined, as the advantage of a slightly cheaper price may be outweighed by the hypothetical increased risk of side-effects from biosimilar molecules that are not exact copies of their originators.
By: Dr. Vivek Rana ProfileResourcesReport error
Access to prime resources