Is India A Success Story With Biosimilar Drugs?

Is India A Success Story With Biosimilar Drugs?

How Indian generic companies are expanding, if not shifting their business focus on biosimilar and complex generic drugs, may be a current trend of general discourse – but the initiative is not a current one. This journey commenced decades ago with an eye on the future. In those days, Indian players were already dominating the global markets of small molecule generic drugs. Interestingly, it started much before the big global players decided to enter into this segment – especially post patent expiry of large molecule blockbuster drugs.

This strategy not just exhibits a sound business rationale, but also benefits patients with affordable access to biosimilar versions of high cost biologic drugs. In this article, I shall dwell on this subject, basically to understand whether India is a success story with large molecule biosimilar drugs, both in terms of drug development, and also in its commercial performance.

India’s journey began with the dawn of the new millennium:

About two decades back from now, some Indian pharma companies decided to step into an uncharted frontier of large molecule biosimilar drugs. According to the ‘Generics and Biosimilars Initiative (GaBI)’, in 2000 – the first biosimilar drug, duly approved by the Drug Controller General of India (DCGI), was launched in the country.  This was hepatitis B vaccine from Wockhardt – Biovac-B.

I hasten to add, in those years, there were no specific regulatory pathways for approval of large molecule biosimilar drugs in India. Thus, the same marketing approval guidelines as applicable to small molecule generic drugs, used to be followed by the DCGI for this purpose. Specific guidelines for biosimilar drugs were implemented on September 15, 2012, which was subsequently updated in August 2016. To date, around 70 large molecule biosimilar drugs, including biopharmaceuticals, have been introduced in India, as the GaBI list indicates.

It is equally important to note that well before any other countries, domestic pharma companies launched in India, AbbVie’s blockbuster Humira (adalimumab) and Roche’s breast cancer treatment Herceptin (trastuzumab). In this context, it is worth mentioning that US-FDA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015.

Will India be a key driver for global biosimilar market growth?

According to the Grand View Research Report of July 2018, increasing focus on biosimilar product development in countries, such as India, China and South Korea, is a major growth driver of the global biosimilar market. As this report indicates, the global biosimilars market size was valued at USD 4.36 billion in 2016, which is expected to record a CAGR of 34.2 percent during 2018-25 period.…continue reading…

Uniting Pharma With Business Ethics: A Bridge Too Far?

Uniting Pharma With Business Ethics: A Bridge Too Far?

Operating ethically not only is the right thing to do but also is fundamental to success in business. Poor governance and poor ethical business practices can lead to fines, public scrutiny and distrust – overshadowing good performance, destroying reputation, and undermining the morale and engagement of employees. …We must act in ways that build and maintain the trust of patients, healthcare professionals, governments and society. This was articulated in the Novartis Corporate Responsibility Report 2017, highlighting how important it is to unite pharma operations with business ethics for each company. But is it happening in reality?

The same question haunts yet again with the announcement of a new Code of Marketing Practice by the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA),effective January 2019. The pronouncement prescribes ‘a global ban on gifts and promotional aids for prescription drugs wherever the association’s member companies operate.’

However, the overall scenario gets more complex to comprehend, when on January 03, 2019  Bloomberg Law reported: ‘The change is causing concern among both U.S.-based and multinational companies like Astra Zeneca, Bristol-Myers Squib, Johnson & Johnson, and Pfizer Inc. about how to balance appropriate business behavior with respect for cultural norms in other countries.’ Interestingly, the IFPMA membership virtually covers all MNC drug companies, operating across the world. Thus, any concern on its implementation, especiallyamong some of the bigger names, raises more questions than answers about its effectiveness. What exactly has been the outcome of all such actions being taken, especially by the multinational pharma industry associations, from time to time. Have the patients been benefited – at all?

Keeping this recent development as the backdrop, I shall try to gauge in this article, is the bridge still too far to mitigate the widening gap between overall pharma operations and the standard of business ethics -voluntary code of practices of pharma associations notwithstanding?

Why pharma ‘business-practices’ and ‘business-ethics’ are so important?

Before charting onto the sensitive areas of ‘business practices’ and ‘business ethics’, let me recapitulate the meaning of these two terminologies to fathom why these are so important in pharma to protect patient health interest.…continue reading…

Does ‘Patient-Centricity’ Now Sound Like A Cliché?

Does ‘Patient-Centricity’ Now Sound Like A Cliché?

Today, many pharma companies claim ‘patient-centricity’ as one of their primary focus areas in business. Many industry experts, as well, have been advocating so, over a period of time. A number of research studies, published during the last several years, also recommended that ‘patient centricity’ should be the key focus area for long-term sustainability of any pharma business, across the world, including India. In the fast unfolding scenario of date, this is absolutely essential to keep pace with the changing needs and aspirations of a new generation of well-informed patients.

Currently, one can easily spot inclusion ‘patient-centricity’ even in the corporate vision and mission statements of many drug companies, especially those with global footprints. But the question arises, how efficient is its implementation in the field?

In this article, I shall try to fathom whether patients are in sync with pharma’s claim of moving towards this goal, or the term ‘patient centricity’ just sounds like a cliché, at least, as of now. Let me start by giving a brief perspective of the subject to illustrate the point, why it represents a fundamental shift in the healthcare space.

‘Patient-centricity’ – a fundamental shift in healthcare space:

As I discussed in my article, titled ‘Increasing Consumerism: A Prime Mover For Change in Healthcare’: ‘Patients’ longing for better participative treatment experience at an affordable cost, has started gathering momentum as a major disrupting force in the healthcare space of India, as well.

This is a fundamental shift in the healthcare space, especially in terms of patients’ behavior, needs, aspirations and expectations while charting across any end-to-end treatment process. This change is taking place over the last couple of decades, pushing many pharma players to adopt a ‘patient-centric’ approach for greater sustainability in the business.

‘Patient-centricity’ has started occupying the center stage in the successful pharma business, as patients are becoming more and more informative. The reasons for this change are many. I have already discussed many of these, along with suggestions on corrective measures, in my various articles, published in this blog on the subject.

What’s happening on the ground?

Drug manufacturers’ various strategic communications aimed at stakeholders, signal that the ball has started rolling. According to a report, well-known pharma majors, such as Novartis, GSK, Janssen Pharmaceutical, UCB, LEO Pharma, among others, are actively participating in conversation on ‘patient-centricity.’ Apace with, a number of research studies also point towards a clear dichotomy, and a glaring disparity between drug companies’ claims and people’s perception of ‘patient-centricity’ in real life. Let me first touch upon the glaring dichotomy in this area.…continue reading…

Pharma’s ‘Value Delivery System’ Still Tuned To A Self-serving Mode?

Pharma’s ‘Value Delivery System’ Still Tuned To A Self-serving Mode?

Just as any other industry, pharma business is also primarily a ‘value delivery system.’ Its each and every employee need to understand and internalize this basic philosophy of the business. This organizational mindset needs to be created by the very top – setting examples for others to embody the same. The top could encompass the promoters themselves, or the professional CEOs – truly heading the organization and not working under the shadow of the promoters, or even the Board of Directors of professionally managed companies.

Although, this mindset should prevail pan organization, pharma sales and marketing functions are usually responsible to deliver a well-thought out set of brand values and associated services to doctors, patients and other stakeholders, effectively.

Against the above backdrop, I shall explore in this article whether it is happening in the pharma industry. If yes, is the ‘value delivery system’ is tuned to a self-serving mode, wherever it is happening? If so, to what extent it is denting the reputation and image of not just of the companies concerned, but of the drug industry as a whole. Before I proceed further, let me elaborate on what exactly I mean by the ‘value delivery system (VDS).’ 

Value Delivery System (VDS):

Creating more and more customers and retaining them, as long as possible, is the core purpose of any business, as was articulated by the management guru Peter Drucker, decades ago. Thus, like others, pharma organizations, as well, require making it happen in a sustainable way for business excellence.

The entire organization – starting from product and service development activities, right up to the frontline sales and marketing, should always be engaged in delighting the customers with the values they expect – driven by this mindset. It is worth noting that value expectations of pharma customers, are expressed in various ways. These need to be properly captured, analyzed, interpreted, packaged and effectively delivered during each company- customer contact, such as, while interacting with doctors, patients, hospitals and Government.

Thus, the term ‘Value Delivery System (VDS), encompasses an integrated chain of processes within an organization. From this perspective, it should get ingrained in the culture of a pharma company – without any broken links – between the functional areas and the integrated value delivery process.

Who is deciding what patients would value in pharma?

In the real world, ‘customers point of view’ or ‘what the patients would value’ in a product, is decided by the pharma companies – derived generally from the published clinical trial results of the products. Accordingly, these are woven around the brand features and benefits.

The value delivery system of the company packages these in a way that it thinks would generate increased prescription demand and delivers to all concerned. These values, which are overall financial business performance-centric, are mostly ‘self-serving’, and was working very well to meet the internal objectives, until recently.

How to ascertain value for patients in pharma marketing?

One way to ascertain these factors is to ask patients directly. But this process has certain limitations. This was once aptly articulated by Steve Jobs in an interview, where he said: ‘I think really great products come from melding two points of view -the technology point of view and the customer point of view. You need both. You can’t just ask customers what they want and then try to give that to them. By the time you get it built, they’ll want something new.’

Taking a cue from it, I reckon, …continue reading…