Generics/Biosimilars

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Healthcare Recruiters from Berke Executive Search Closely Monitor Generics/Biosimilars Industry

The Generics/Biosimilars sector is one of particular depth and experience at Berke. Over our 30-year history, we have executed searches for most of the key players in this sector, along with those on track to become key players over time. We have staffed the “C” level suite at a number of the leading Generic companies and continued to serve many as they transitioned into branded products as well. We have a complete understanding of the unique challenges that executives face with the FDA, payors, distributors and consumers and the differentiated needs that they create.

Thanks to the Affordable Care Act that was passed by Obama in 2010, the number of Americans living without healthcare has already fallen by 2.2%.  However, because of the continual rise of healthcare costs, more and more third-party medical organizations have begun to see an increased demand for generic drugs over brand-name drugs. As a result, fierce competition between generic and brand-name pharmaceutical manufacturing companies have caused the drug costs to decline and caught the attention of the American government. In response, the FDA has recently proposed that all pharmaceutical labels include product liability, a move that will raise the amount of money that is spent on generic drugs to 4 billion dollars.

The Definition of a ‘Generic Drug’

The use of generic drugs has shot up exponentially in the past three decades and not only because of their significantly lower cost. In 1984 only 19% of all prescriptions were generic drugs; in 2010 this number jumped up to 78%. The reason more and more people are beginning to trust generic drugs is because of a growing awareness as to what generic drugs really are. According to the FDA, generic pharmaceuticals are, “copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug.” Customers now know that when they purchase brand name products they are only paying for the label as the generic counterparts are identical in every other way.

The Generic Drug Industry

The nature of the generics business is unlike that of any other. These companies are developing, testing and marketing off-patent drugs, which are bioequivalent to the innovator product. The timetables, regulatory interface, materials procurement, manufacturing schedules and sales teams are very different than those in a Branded Pharma company. It takes special talent to operate and be successful in such a demanding environment and, over the years, Berke has learned exactly what it takes and we deliver those candidates. Providing such people is an art and relies to a high degree on personal relationships and an intimate knowledge of industry executives, both leaders and rising stars.

The Generic Drug sector has gained a higher market share than branded pharmaceuticals. By 2012, the global generics sector was up to $269.8 billion and is expected to increase up to 518.5 billion by 2018. Despite the success of this market, new competition between vendors could stifle the profitable growth of the generic drug industry. Emerging markets in China, Russia, India, Brazil, South Korea, and Turkey are also expected to see a 15%-20% annual increase for generic drugs.

What Are Biosimilars?

Biosimilars are products that are very similar in nature to FDA licensed biological products. There are however some differences including the potency, purity, and safety of the product.

Current Trends in the Biosimilars Industry

According to the FDA’s U.S. Food and Drug Administration, “The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.” Prior to this Act there weren’t as heavily established guidelines for the legislature that makes sure biosimilar products are more safe and effective. Furthermore, according to Genetic Engineering & Biotechnology News, the market shares for biosimilars are expected to rise from 1% in 2014 to 10% in 2020 increasing their value from $1.9 billion to $25 billion.

In 2013, the industry revenue for publically held companies is estimated at $98.8 billion with U.S. companies making a total of $71.9 billion annually. In addition, biotech drugs make up a total of 10% of worldwide prescriptions. Meanwhile, prescription drugs in the states totalled $275.9 billion in 2014 – that’s over $900 per capita.


Berke Executive Search’s healthcare recruiters are consistently keeping up to date with the changing trends of the generic and branded pharmaceutical industries to ensure that only the most qualified and knowledgeable talent is found for hiring managers. The talent required to run these global enterprises is very different than the teams that founded and grew these companies and Berke is involved in helping these clients make the transition. To learn more about the healthcare recruiting services our team offers at Berke Search, visit our website or contact a team member at http://www.berkesearch.com/.

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At Berke Executive Search, our pharmaceutical and biotech recruiters conduct highly specialized searches and assessments to ensure that your talent acquisitions exceed expectation and contribute to the growth of your business, allowing you to emerge as a global presence.

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