Scandalizing Biosimilar Drugs with Safety Concerns

Scandalizing Biosimilar Drugs with Safety Concerns

With the patent expiry of exorbitantly priced biologic medicines, introduction of biosimilar drugs are expected to improve their access to millions of patients across the world, saving billions of dollars in healthcare costs in the subsequent years. According to an article published in Forbes, it is estimated that the potential savings in the United States alone from just 11 biosimilar drugs over a period ranging from 2014 to 2024 could easily be U$250 billion.

However, the flip side of this much awaited development would make commensurate dent on the sales performance of original brand name biologics, now being marketed by the global pharma majors armed with patent monopoly rights.

Innovating hurdles to negate the impact:

Facing this stark reality, global innovators of biotech drugs allegedly want to fast germinate a strong apprehension in the minds of all concerned on the safety and replaceability of biosimilar drugs. Consequently, this would severely restrict the usage of this new class of products, sacrificing patients’ health interest.

To translate this grand plan into reality, garnering additional support from ten medical societies and a physicians’ group, the global players, which mostly hold various patents on biologics, reportedly urged the USFDA to require biosimilars to have distinct names from the original biologics, on the pretext that different names would make it easier for prescribers to distinguish between medicines that “may differ slightly” and also track adverse events and side effect reports that appear in patient records.

However, other stakeholders have negated this move, which is predominantly to make sure that no substitution of high priced original biologics takes place with the cheaper versions of equivalent biosimilars to save on drug costs.

Intense lobbying to push the envelope:

Interestingly, this intense lobbying initiative of big pharma to assign a distinct or different name for biosimilar drugs, if accepted by the USFDA, would provide a clear and cutting-edge commercial advantage to the concerned pharma and biotech majors, even much after their respective biologic drugs go off patent.

Thus, the above allegedly concerted move does not surprise many.

Mounting protests against industry move:

Biosimilar drug makers, on the other hand, have suggested to the USFDA to make biosimilars fall under the same International Non-Proprietary Name (INN) system, like all generic prescription drugs.  They believe that new names would create confusion and the physicians and pharmacists may face difficulties in ascertaining whether biosimilar drugs serve the same purpose with similar dosing and regimens.

The protest seems to have a snowballing effect. In July 2014, by a letter to the Commissioner Hamburg of USFDA, different groups representing pharmacy, labor unions, health insurance plans and others, have reportedly urged her not to go for different INNs for the original biologic and a biosimilar drug, for the same reason as cited above. The letter reinforces that the industry move, if accepted by the USFDA could increase the possibility of medication errors, besides adversely affecting the substitution required to bring down overall health care costs for high priced specialized biologics, thereby slowing down the uptake of biosimilars significantly.

Global pharma investors also raising voices in support of biosimilars:

Another similar and major development followed soon. A letter titled, “Investor Statement on Board Oversight of Biosimilar Issues”, written by a group of 19 institutional investors that manages about US$430 billion in assets, to the boards of several big pharma and biotech companies, flagged that some pharma majors have been scandalizing the safety concerns of biosimilar drugs. This is happening despite the fact that this class of drugs already has a well-established track record in Europe.

They emphasize that recent actions taken by some big pharma companies could raise concerns on the overall acceptance of biosimilar drugs, which would forestall any projected savings on that subject. They also reportedly expressed serious concern that shareholder interests could be adversely affected, if the pharma and biotech players pursue those policies that undermine corporate transparency and medical innovation.

The letter underscores, “Companies seeking to downplay the patient safety record of European biosimilars have also challenged the capacity of the FDA to promulgate rules and determine when biosimilars may be substituted for biologics.”

Among other points, the letter reiterates:

• Though the important role of biologics in treating cancer, rheumatoid arthritis, anemia, multiple sclerosis and many other conditions is well recognized, the costs of these medicines are on an unsustainable trajectory, with some biologics costing as much 22 times more than other drugs. This critical issue seriously impedes patients’ access to biologics, as well as, acceptance by providers and insurance companies.

• Biosimilars hold the promise of lowering costs of treating conditions for which biologics are indicated. At the same time, the recent adoption of a regulatory pathway to approval of biosimilars in the US market and the continued growth of biosimilars in the European Union, Japan, Canada, Australia and South Korea, pose a formidable business challenge for the companies that market patented biologic medicines.

• Financial experts project that biosimilars too have the potential for significant market penetration and attractive returns on investments.

• Assigning different INN would communicate to providers that the biosimilar is less effective, prompting them not to prescribe this class of medicines and making it difficult for the pharmacists to dispense too. Besides, different names could lead to prescribing errors.

• In short, the boards of directors of the pharma and biotech majors were urged by these investors to use the following principles to guide their decision-making related to biosimilars:

-       Policy and educational information provided on biosimilars should be balanced, accurate and informed by the patient safety experience of biosimilars in the European Union and other biosimilar drug markets.

-       Lobbying expenditures for federal and state activities related to biosimilars should be fully disclosed and the boards should ensure that political activities are aligned with the interests of investors and other stakeholders.

-       Key information about any partnership or business deal related to biosimilars should be fully disclosed to investors, including information about the value, terms and duration of the deal.

The WHO proposal:

In this context it is worth recapitulating, the World Health Organization (WHO) that oversees the global INN system has held a number of meetings to resolve this issue. TheWHO proposal suggests that the current system for choosing INNs to remain unchanged, but that a four-letter code would be attached at the end of every drug name. However, individual regulatory agencies in each country could choose whether to adopt such coding or not.

Let us wait to see what really pans out of this flexible WHO proposal on the subject.

Biosimilars go through stringent regulatory review:

It is important to note that the drug regulators carefully review biosimilars before giving marketing approval for any market, as these drugs must prove to be highly similar without any clinically meaningful differences from the original biologic molecules. The interchangeability between biosimilars and the original biologics must also be unquestionably demonstrated to be qualified for being substitutable at the pharmacy level without the need for intervention by a physician.

Thus, there does not seem to be any basis for different INN, other than to severely restrict competition from biosimilars.

12-year data exclusivity period for biologics – another hurdle created earlier:

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Patented Drug Pricing: Relevance to R&D Investments

Patented Drug Pricing: Relevance to R&D Investments

The costs of most of the new life saving drugs, used in the treatment of dreaded diseases such as cancer, have now started going north at a brisk pace, more than ever before.

From the global pharma industry perspective, the standard answer to this disturbing phenomenon has remained unchanged over a period of time. It continues to argue; with the same old emphasis and much challenged details that the high drug price is due to rapidly escalating R&D expenses.

However, experts have reasons to believe that irrespective of R&D costs, the companies stretch the new drug prices to the farthest edge to maximize profits. Generation of highest possible revenue for the product is the goal. Passing on the benefits of the new drug to a large number of patients does not matter, at all.

How credible is the industry argument?

In this context, let me take the example of Hepatitis C drug – Sovaldi of Gilead. Many now know that for each patient Sovaldi costs US$ 30,000 a month and US$ 84,000 for a treatment course.

According to an article published in Forbes, one health executive estimated that the annual price tag for Sovaldi could reach US$ 300 Billion because so many people have Hepatitis C infection worldwide.  This mindboggling amount is more than all spending on all drugs in the United States, currently.  A more realistic number might be between US$7 Billion and $12 Billion a year.  Even that amount is roughly five times the amount Gilead spends each year on research.

Like Sovaldi, in many other instances too, industry argument of recovering high R&D investment through product pricing would fall flat on its face.

Need to put all the cards on the table:

The distinguished author underscores in his article the expected responsibilities of the experts in this area to ask the global pharma industry to connect the dots for all us between:

• The societal goals they aim to achieve
• The costs they incur on R&D
• The profits they should reasonably be earning.

Public investments in R&D:

Another article titled, “Putting Price On Life”, argues that R&D projects are mainly initiated in the public sphere through tax-funded research. Unfortunately, patients do not derive any benefit of these public investments in terms of reduction in prices for the related drugs. On the contrary, they effectively pay for these new products twice – once through tax-funded research and then paying full purchase price of the same drug.

Additionally, industry corners the praise for the work done by others in tax-funded research, while at the same time making R&D less risky, as public funded research groups carry out most of the initial risk prone and breakthrough innovation.

The article also highlights that global pharma companies receive other tax credits over billions of dollars for their expenditure on R&D. However, the R&D figures that are produced are not adjusted to take into account the tax credits, thereby inflating costs and the prices of drugs.

All these tax credits significantly lower the private costs of doing the R&D in the United States, increasing the private returns. Interestingly, there does not seem to be any public information regarding who gets the tax credit and what the credit is used for, while the government does not retain any rights in the R&D.

Does pharma R&D always create novel drugs?

According to a report, US-FDA approved 667 new drugs from 2000 to 2007. Out of these only 75 (11 percent) were innovative molecules having much superior therapeutic profile than the available drugs. However, more than 80 percent of 667 approved molecules were not found to be better than those, which are already available in the market.

Thus, the question that very often being raised by many is, why so much money is spent on discovery and development of ‘me-too’ drugs, and thereafter on aggressive marketing for their prescription generation? This is important, as the patients pay for the entire cost of such drugs including the profit, after being prescribed by the doctors?

Should Pharma R&D move away from its traditional models?

The critical point to ponder today, should the pharmaceutical R&D now move from its traditional comfort zone of expensive one company initiative to a much less charted frontier of sharing drug discovery involving many players? If this approach gains acceptance sooner, it could lead to significant increase in R&D productivity at a much lesser cost, benefiting the patients at large.

Finding the right pathway in this direction is more important today than ever before, as the R&D productivity of the global pharmaceutical industry, in general, keeps going south and that too at a faster pace.

Current IPR mechanism failing to deliver:

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Alzheimer’s Disease - Robs Memory: Steals Dignity: Escapes Treatment

Alzheimer’s Disease - Robs Memory: Steals Dignity: Escapes Treatment

At a well reputed Mumbai Club, quite unexpectedIy, I bumped into Sumeet (name changed). It has indeed been a long while since we met at his home in South Mumbai. He came there with his wife Shilpa (name changed). Sumeet, was literally an icon of yesteryears in every respect, a bright engineer with MBA and a much-accomplished leader of his time who retired at the turn of the new millennium.

“How are you Sumeet da?”, I started off cheerfully, as he was looking all around.

“Very well, very well and you?”, he replied softly with a faint quivering of his lips, but without any eye contact.

“I am good Sumeet da, but have you recognized me?” I queried with apprehension.

Turning his face towards Shilpa, Sumeet hesitatingly replied, “No. But have we met before?”

The innocent question struck me as lightning from nowhere, making me a bundle of emotion momentarily. With a lump in my throat and clenching my fists, I struggled hard to regain my composure.

Sumeet, one of the the brightest of brights, from earlier years of our generation, is now a victim of a dreaded illness called Alzheimer’s Disease (AD). The disease has robbed him of his priceless memory, changed his behavior beyond recognition, kidnapped him from his own self, and has stolen most of his much-valued dignity in life, mercilessly.

Alzheimer’s Disease (AD) in brief:

Alzheimer’s Disease (AD), as known to many, is the most common form of dementia, accounting for 60 to 80 percent of all cases, that results in serious memory loss and other intellectual and behavioral traits of individuals, serious enough to interfere with a person’s daily life and tasks.

AD has been defined as, a neurodegenerative type of dementia, in which the death of brain cells causes memory loss and cognitive decline. The total brain size shrinks with AD, as the tissue has progressively fewer nerve cells and connections. Brains affected by AD would always show tiny inclusions in the nerve tissue, called plaques and tangles.

Plaques are found between the dying cells in the brain – from the build-up of a protein called beta-amyloid, while the tangles are within the brain neurons and from a disintegration of another protein, called tau.

Though the abnormal protein clumps and inclusions in the brain tissues are always present in AD, there could be another underlying process also that is actually causing the disease, which scientists are not sure of, as yet.

Be that as it may, with the progression of the disease, besides memory loss, AD precipitates other serious symptoms, such as, deepening confusion about events, time and place; mood and behavior changes; unfounded suspicions about family, friends and even professional caregivers; disorientation; other behavior changes; then difficulty speaking, swallowing and walking. At a late stage, the patients lose the ability to carry on even a conversation and respond to their environment.

Cause:

Although the causes of AD are not quite clear to the scientists, as yet, the disease results from a combination of genetic, lifestyle and environmental factors that adversely affect the brain over a period of time.

Scientists opine that in less than 5 percent of the cases, the causative factors of the AD are specific genetic changes that can almost definitively indicate that a person would develop AD. According to published reports, while the strongest risk gene found so far is apolipoprotein e4 (APOE e4), other risk genes have not been conclusively confirmed, just yet.

Survival rate:

According to published reports, the survival rate of AD patients, after their symptoms become noticeable to others, can range from 4 to 20 years, depending on health conditions, the average being 8 years. In the United States, AD is the sixth leading cause of death.

Not a normal part of the aging process:

Although majority of people with AD are over 60 years of age, it is not just a disease of old age. Up to 5 percent of cases the disease may strike even younger people in 40s or 50s. Women are found to be more prone to AD than men.

Prevalence:

The World Health Organization (WHO) declared dementia, in general, as a priority condition in 2008, through the Mental Health Gap Action Program.

Each year, the total number of new cases of dementia worldwide has been reported as nearly 7.7 million, which means one new case every four seconds.

According to AC Immune SA of Switzerland, AD will be one of the biggest burdens of the future society showing dramatic incidence rates. Over 44 million people were now affected with AD worldwide. Since the incidence and prevalence of AD increase with age, the number of patients will grow dramatically as our society gets older. By 2050 the patient numbers are expected to triple, touching 135 million AD patients worldwide.

India:

According to another report titled, “Priority Medicines for Europe and the World – A Public Health Approach to Innovation” By Béatrice Duthey, Ph.D published on 20 February 2013, the fastest growth of AD in the elderly population is now taking place in China, India, and their south Asian and western Pacific neighbors and has become a major public health concern as the population ages.

AD is the most common kind neurodegenerative disease in India. There are reportedly around 5 million dementia patients in the country of which, roughly 70 to 80 per cent have AD. This number is expected to double by 2030, and the costs involved are expected to increase three times. Besides drugs, costs of ‘care giving’ for AD patients are also expected to rise significantly.

The market and economic impact:

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