Generic Biologics As A Tool For Evaluating The Safety And Efficacy

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

The implementation of the Affordable Care Act (ACA) will only hasten changes that were on the horizon for pharmaceutical and biotechnology firms. Pharmaceutical and biotechnology industries new there was going to be some type of healthcare reform so they began to take the necessary precautions to prepare. There are vital provisions in the ACA related to the pharmaceutical and biotechnology industry affecting Medicare and Medicaid. Legislation in the ACA will provide provision to reduce cost for brand name prescriptions (Rx); this will reduce drug cost for patients, but increase rebates and discounts for pharmaceutical and biotechnology firms, therefore, imposing cost to the firms. The pharmaceutical and biotech industry was instrumental

Extremely risky drug discovery and development, lengthening development times which increase development cost, return on investments, and generic competitors.

These new guidelines will allow for a 12-year period of data exclusivity for new branded biologics. During the 12- year period, rivals are not allowed to use any prior data to try to come up with their own product. Before, the passage of the ACA, the Federal Drug Administration (FDA), could not legally approve new biologic medicines because they had to have clinical trials. This law opened up the regulatory guidelines for the FDA to approve

Medication has also become increasingly complex. There has been a massive increase in the number and variety of medications available. In addition, many medications have different routes of delivery, variable actions (long acting, short

A reason for that is that the introduction of biosimilars is expected to reduce drug costs, although to a lesser degree than seen with small-molecule generic drugs. This difference can be explained due to the importance of clinical trials in the case of biosimilars, as the process is fully part of the final drug : Generic medicines need to

With the huge diversity and changeability of human biology, it is impossible to imagine a reality without some mutations, changes, or issues in the organs and tissues of humans. Thus, it rightly follows that medications and pharmaceuticals have been created in an effort to counteract the various ailments and illnesses that people can experience. However, as time has gone on and these pharmaceuticals have become more and more high-tech, regulated, and trusted, they have also become incredibly commercialized. Worse still, medications have become incredibly expensive and can be unattainable for some people.

E. Generic drugs can have different manufacturers, which mean they can also have different inactive ingredients in it.

Even though the capital requirements are less demanding in generic pharmaceuticals, it is still a very expensive venture and extremely competitive, making it hard to penetrate as well. The biosimilar industry is undeveloped and competition is scarce, but it takes a lot of money and expertise to produce products that are as complex as these pharmaceuticals.

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).

Achieve a median composite eight-year product development cycle by 2010. Deliver two new molecular entity (NME) launches on average per year from 2010. In order to achieve the above objective, ensure that we have 10 or more NMEs in Phase III development by 2010. Development cycle times and quality for small molecules and biologics. Number of NME launches per year. Attrition rates. Number of development projects by phase. Number of in-licensing deals, alliances and acquisitions. R&D investment levels. Improving R&D quality and speed through leading-edge science, effective risk management and decision-making and overall business efficiency. Maximising the value of our biologics business and continuing to build a major presence in this fast-growing sector. Investing in external opportunities to enhance our internal innovation through in-licensing, alliances and acquisitions. 2008 target exceeded for small molecule development cycle times. NME and life-cycle management progressions

A contract manufacturing company has been analysing a tablet product by the method described in the British Pharmacopoeia (BP) monograph. This is the method detailed on the product License and BP methods are generally considered to be validated. After trend analysis for the annual Product Quality Review (PQR) report, it has been discovered that 5 batches were rejected in 2013 due to high out of specification assay results. Furthermore, several batches had assay values close to the upper specification limit. The release specification limits for the product are 95-105%.

ISSN: 2277- 7695 TPI 2014; 3(7): 08-12 © 2013 TPI www.thepharmajournal.com Received: 14-08-2014 Accepted: 28-08-2014 Rizwan Raheem Ahmed Professor, Department of Business Administration & Commerce Indus University, Pakistan