Category Archives: Bio-equivalence Studies

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The Indian generic drug industry is the largest supplier of medicines worldwide and US is the largest consumer of the same. One of the leading companies, a leading generic manufacturer which is also the leading supplier of generic medicines to the US has come under the FDA scanner since the last 12 months.  The trigger to the Ranbaxy problems came when Dinesh Thakur , ex-Ranbaxy employee, acted as the whistleblower. The same came out as an action from the FDA when Ranbaxy’s key manufacturing plants in India went on a spree of Imports alerts and 483’s. To add to the problems, even Ranbaxy’s’ US based plants came under the FDA lens.

 The problems were many:

  • Response from the Indian regulated DCGI to the Ranbaxy fiasco came only after the FDA warnings to Ranbaxy
  •  Internal conflict within Ranbaxy between the ex-owners, Malvinder Singh and Diachii Sankyo occupied the front pages of the media Continue reading

The Indian Clinical Research Industry is going through a tough phase. Business in the industry is competitive because of a price war and a very stringent regulatory environment. The market was expected to reach a $ 1 billion in 2010 with a predicted growth rate of 15-20% but because of the prevailing recession and above mentioned factors, the market has yet to reach a size of $800 million in the year 2012-2013. The Industry desperately needs a growth booster. Experts of the industry also need to change the way they think about moving forward. Continue reading

The National Symposium on Bioequivalence Studies & Generic Product Development is a unique platform for senior scientists to come together and share the experiences they have had solving the day to day problems especially where the guidelines are silent or their past experience is not adequate.  Increasingly this is a common problem  because of the fast changing regulatory environment and demands of the industry. The audience will gain a lot by participating in the discussions with these bright minds and question their experiences in a most candid manner.

This event is not  intended for networking but rather, to pave the way in sharpening our scientific minds and  to once again place  India at the forefront of technology for generic drug development after a very difficult year for the whole industry, both at home and in the global arena.

In order to achieve the maximum impact we have planned four such events across the country starting from Ahmedabad followed by Mumbai, Hyderabad and Delhi.

The fees for this event will be kept very affordable in order for the companies to send their middle and lower level scientists and for the students and faculty to participate and learn as well.   In particular, many students enter the workplace with mostly theoretical knowledge and a lack  experience at the lab bench. We are trying to address this issue in a very practical  way by making  it affordable for students in their final year to come and do work-placements so that they  absorb the real world issues and their solutions.  This will help in bridging the gap between their college educational and business needs. We will also have a job fair where they get to interact with the scientists from the industry.

More details at:http://www.acroindia.org/news/BrochureACROSV.pdf

National Symposium on Bioequivalence Studies & Generic Product Development

National Symposium on Bioequivalence Studies & Generic Product Development

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Generic drugs are certainly a significant part of the landscape in the healthcare world. Not only do they save healthcare consumers (and their insurance companies) millions of dollars a year, but they are a thriving industry in their own right. Companies like India’s Dr. Reddy’s Laboratories and its nearly ten-fold larger rival Teva Pharmaceuticals have certainly produced ample rewards for long-term investors.

Now, though, there is a whole new window of opportunity opening for the generics companies – the opportunity to sell what amount to generic versions of biopharmaceuticals. Though the path will be difficult and expensive, this market represents a major opportunity for the generics industry and potentially a major threat for many large pharmaceutical companies.

The Story So Far
To be clear, the opportunity in biosimilars is not exactly “”new””, but prior rules (and the uncertainty of how the FDA would apply those rules) largely kept this market empty. Now, though, with the Pathway for Biosimilars Act of 2009 and the Patient Protection and Affordable Care Act of 2010, there is more clarity than before and a reasonably clear mandate from the U.S. Congress for the FDA to act more openly and decisive.

The Problem
In simple terms, biosimilars are generic versions of biologic drugs. While many drugs used to be developed and produced through chemical processes, biologic drugs are produced through biological processes that generally involve recombinant DNA technologies. Famous examples include Amgen’s Epogen and Enbrel, Abbott Labs’ (NYSE:ABT) Humira, and the insulins produced by companies like Sanofi-Aventis and Novo Nordisk.

Although copying a traditional pharmaceutical is a relatively straightforward affair for chemists (though not all drugs are easy by any means), the process of copying biologics is more complicated. Would-be competitors are not going to get access to the original cell lines, nor are branded pharmaceutical companies going to share the particulars of their fermentation or purification processes. What that means, then, is that it is more difficult for the generics company to establish that their candidate is identical to the product it proposes to copy.

Consequently, there has been a great deal of discussion and debate about just what sort of standards the generic competitor must meet. Large drug companies, fearing the loss of lucrative markets, have agitated fiercely for rigorous safety and equivalency trials, and some doctors and patient safety advocates have certainly joined them in this. On the other hand, representatives for generic drug companies and those who pay for the drugs (including insurance companies) have argued that the process are unnecessarily cumbersome and difficult – so much so that a company will not make the substantial upfront investments needed to produce biosimilars only to be jerked around by the FDA.”

“The need to curb the rising costs of healthcare has led policy makers in many countries to consider generic substitution of various brand name drugs as na effective means to cut costs.
For example, NHS in England began a 3-month consultation to seek views on plans to automatically substitute branded drugs with generic versions in primary care. However, doctors, patients, and advocacy groups—in England and elsewhere—are concerned that generic antiepileptic drugs (AEDs) might not be therapeutically equivalent to branded drugs, which could put patients at risk of breakthrough seizures or other adverse events. Thus, any proposal to implement widespread generic substitution needs careful consideration.
Anecdotal evidence, case reports, and database reviews have suggested an association between generic switching and poor outcomes. According to a retrospective review of medical and pharmacy claims in Canada, the rates of switchback (switching back to a branded drug after generic substitution) were greater for AEDs than for non- AEDs, and health-care costs were greater in patients who received generic topiramate compared with the branded version. Furthermore, the risk of head injury or fracture was almost three times greater in patients who switched from one generic version of topiramate to another, compared with patients who continued on the branded version. However, good-quality prospective data on outcomes after switching are lacking, and the view of the US Food and Drug Administration (FDA) is that approved branded and generic drugs can be used interchangeably.
The FDA and the European Medicines Agency have strict standards for approval of generic drugs: a generic drug is deemed to be equivalent to a branded drug if
the 90% confi dence intervals for the mean of several key pharmacokinetic parameters for a generic drug are within 80–125% of those of the brand-name drug.
However, such bioequivalence studies are done in small numbers of healthy volunteers and may not be generalisable to patients with epilepsy. Furthermore,
the narrow therapeutic range of AEDs means that drug concentrations must be maintained within a narrow window to be eff ective. Variations from this therapeutic range, even by a small margin, can increase the risk of detrimental out comes. Switching between diff erent generic versions is particularly problematic: two different generic drugs could, in theory, have bioequivalence values at the two extremes of the 80–125% range, causing large fl uctuations in serum concentrations if patients switch from one generic version to another. Although generic switching is unlikely to be problematic for many patients, experts believe that there may be a subset of patients who might be more susceptible to variations in AED concentrations.”

The Top Listed CRO companies are facing tremendous pressure on their margins. Many are unable to maintain the same and are running into losses into millions of dollars each quarter. Quarterly results published every quarter and webcasts on the respective website speak for the same. With Global MNC’s slashing their drug development pipelines and trying to “”move”” restrictively and with caution in the clinical development market, it becomes quite clear that the CRO’s which are dependent on the outsourcing of these trials would have to revise their forecasts in order to survive or would have to struggle to stay competitive. Investments in the direction of investment would be once again very “”aggressive”” and ROI in a limited time frame may not be guaranteed. This would be coupled with an excessive amount of regulatory pressures as well.
CRO’s would need to have business blend /Business model which strikes a balance towards the market competiveness, investor pressures, pressures on profitability, maintaining head counts , currency effects, outsourcing shifts to cost effective emerging markets, etc in the times to come. Recession has influenced the business model of companies particularly CRO’s. One of the companies is MDS Inc, a listed Canadian CRO which has recently placed its restructuring programme and declared that it would sell off its Central labs to Czura Thornton, the PE group of Chiltern International.
MDS Inc. history speaks for itself
HISTORY-
The history of MDS in the last 2-3 years has not been particularly favourable in terms of profitability and subsequently its growth. MDS has been facing major problems with the FDA since 2006-2007 on account of “”data falsification”” and has been made to repeat the studies for the entire year under serious FDA warnings. This has lead to a “”shutdown”” of its Quebec facility in Canada.
MDS has been on the lookout for a buyer since the last 1 year for some of its services particularly during the market crash due to recession in the the year 2008(last quarter of the calendar year).More details at –
MDS BUSINESS STRATEGY- POSITIONING IN BIO EQUIVALENCE STUDIES
The company , MDS Pharma has recently placed itself with an ANVISA accredition for all its sites in the USA which are detailed at:
http://www.outsourcing-pharma.com/Clinical-Development/MDS-sites-gain-Brazilian-regulatory-certification .The company is planing to position itself in Early phase and BA BE studies which is clear from its sell out of its late stage toCzura Thornton , the PE group of Chiltern. Chiltern will benefit as its services in Central labs will have a blanket coverage across geographies in six sites in Europe, North America and Asia and will aid its clinical development services in those regions.
MDS has sold off its late stage services to INC research in June 2008-

http://www.outsourcing-pharma.com/Clinical-Development/MDS-sells-late-stage-trial-unit-to-INC-Research

STRUGGLE FOR SURVIVAL -MDS LOSSES WERE MOUNTING in Q2
MDS Pharma Services posted an 18 per cent drop in revenue in its Q2 results, which also contained details of restructuring that will affect 180 people and cost $4m (€2.8m).

http://www.outsourcing-pharma.com/Preclinical-Research/MDS-posts-17m-loss-as-pharma-services-revenues-drop

The repositioning strategy is an example of the changing demands of the Global Pharma and the policy shifts of the Western world towards promoting cost generic drugs which would ultimately from the basis of the outsourcing market i.e. Bio Equivalence studies which in the next FY would be expected to take a double digit growth turn.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.

“Many wise men on this earth have said that fear disappears when the facts are faced with courage and patience.
Similar is true for the drug industry in today’s’ recessed times. Many key Global MNC CEOs’ and management professionals have admitted that it has been not only a painful task but also a fearful task of revamping their growth strategies and business in the recessed times. They have succeeded in their own way but fear has not crept towards them as they have faced the appropriate facts in the most accurate way to realign company goals with employee needs towards a better future. Looking at the way today the drug industry is moving there are only two things that Global drug industry is looking at: One is a cost effective generic presence in a cost effective generic market.
The “”Fearless and Untiring”” efforts towards generics in full swing in the drug industry today are available from their freely available press releases and statements from company correspondents from freely available internet sources. The trends towards generics indicate that the drug market is striving towards a stable environment of safe and cost effective generic drugs which the end consumer can take without any “”fear’ because the same would be equivalent to the parent /reference drug.
Drug companies which manufacture generic drug products sell their products only after conducting relevant Bio-equivalence studies. The same are outsourced to the preferential CRO which the drug manufacturer chooses based on a certain well defined regulatory criterion of its own.
Veeda Clinical Research is a well known Indian CRO which conducts bio-equivalence studies for the drug industry. ”

“The generic drug industry is expected to strike wonders for all those people who cannot afford to buy expensive branded drugs in their country not only in the developed nations but also the developing nations.
The developing would look forward to treating their illness with generic drugs for reasons which are economy driven, affordability and their health insurance coverage and government policies in the respective countries of interest.
The developing world nations (example African countries) would look at the generics merely on availability and the disease prevalence. Common diseases like Malaria, Tuberculosis, AIDS and associated diseases prevail in these countries and play havoc in the lives of the common people. Most of the supplies of generic drugs are available in the developing countries like Africa through their governments. Major Indian Pharmaceutical companies are suppliers of various generic anti-retro viral drugs to the governments of the developed countries on an annual contract renewal basis namely example Cipla, Lupin, etc. to name a few.
For all such generic equivalents or copy cat drug supplies to the countries of interest for the Indian Pharma world (regulated or semi regulated markets), the theorem which is to be proved is the Bio-Equivalence “”Theorem””.
The Bio-Equivalence “”Theorem””- Generic drug = Branded Drug.
The companies which manufacture generic drugs have to conduct bioequivalence studies before they can export them outside India. These studies are outsourced to the CRO (clinical research outsourcing) of their interest. Veeda Clinical research is an Indian CRO which provides Bio equivalence services to the Pharmaceutical industry and proves the Bio- equivalence Theorem. “

“The treatments for the known and the unknown are being provided by the drug industry in a big way. The drug industry aims to provide treatments which are not only cost effective & reach the masses in a big way but also treatments which are safe. Safe treatments are those treatments which provide cure to the ailing with minimum side effects & minimum harm.The safest drugs available for treatment today are the off patent drugs i.e. the generic drugs. The pharmacokinetic profile of generic drugs is “”known “”. The possible reactions and relevant actions of generic drugs in the human body are known and proven over a period of time. The risk map of the drugs to the human body can be drawn at nay period of time.
Establishing a bio-equivalence of a branded drug (off patent) with its generic version becomes the objective of proving the effectiveness of a generic drug in a healthy human body.
Studies which are conducted for the same are known as bioequivalence studies (BA-BE studies) and companies which conducts these studies in a major way are able to establish their presence in a major way in the generic outsourcing market.
The leading provider of such services today is Veeda Clinical Research which not only works the cost effective way but also ensures the existence of SAFE and steady path as a renowned outsourcing provider. “

Across the world there is a motto which is moving across the world such as save water, save energy and last but not the least save for the future. The drug industry is no exception to this motto. The drug industry aims at providing treatments for the known disease pattern in a major way. A lot of the unknown disease pattern is targeted by the hefty research and development budgets of the industry.
The drug industry talks of reaching the masses in a major way. For doing so, it takes the help of the ruling government authority of that country to succeed in its plans. In the developed nations where government policies are responsible for reimbursing health care costs to the masses like USA & Europe, the healthcare focus would aim at providing cost effective healthcare to all. For the known disease patterns, off patent versions of existing known as generics prove to be the most suitable from all aspects of healthcare reimbursements.

The US government and the European government and their associated bodies are all in favor of saving healthcare costs in a major way by encouraging usage of ONLY generics in their respective countries. This is best method of SAVING lives by SAVING on Healthcare costs.
All generics need to be bioequivalent to the original patented drug. They can be proven to be bioequivalent to a patented drug if tested in a study on healthy human volunteers. The companies which conduct these kind of studies for the drug industry are called are CRO’s .i.e. Clinical Research Outsourcing providers.
Veeda clinical research aims at providing BA-BE studies to prove that generics are as bioequivalent as the patented drug in a major way.

Veeda is the service provider with a “SAVINGS “approach for the world’s drug industry.