Makovsky Leadership Educates Industry on Biosimilars

Biotech Products May Soon Face New Competition Under Healthcare Reform

NEW YORK, FEBRUARY 24, 2010 - Makovsky + Company Health Practice leaders, Gil Bashe, executive vice president, and Kristie Kuhl, JD, senior vice president, will be featured presenters at two industry conferences on biosimilars where they will examine the regulatory and patient safety pathway facing  Congress, Food and Drug and Administration, and innovator and generic industries.   The two are invited panelists and moderators at  the Sixth Annual Global Biosimilars Conference in Boston, March 2^nd to 4^th and two weeks later at the Fourth Annual Summit on Biosimilars hosted by CBI in Washington, DC, March 18^th and 19^th.

Biologics are the fastest-growing class of therapies in the United States and financial analysts predict the sector will provide more than 50 percent of new medicines in the next two years.  However, a substantial number of blockbuster biotechnology drugs are off patent or facing imminent patent expiration, opening the door to follow-on biologics or biosimilars—termed by some “biogenerics.”  The challenge for these new entrants is addressing patient-safety and manufacturing concerns that these products are “similar” and not bioequivalent.  

“Follow-on biologics may create new surprises for payers, physicians and patients.  Unlike a generic version heart-protecting statin or allergy-tackling tablet, biotech products are expensive to produce and small changes to the biologics often result in dangerous patient immune-response reactions,” notes Gil Bashe, EVP, Makovsky Health Practice Director, who co-chaired the CBI DC Biosimilars gathering in 2009. “It’s possible newcomers to the biosimilar field will be biotech originators that have the manufacturing facilities and research skills in place to address these questions.”

The biosimilar space is not a new area for the Makovsky team.  The Agency began working with clients in 2002 to explain to innovators and those seeking to advance biosimilars that this complex category required understanding unique from traditional small-molecule generics.

“For biosimilar developers the science becomes the sticking point for interchangeability,” said Kristie Kuhl, JD, SVP, Makovsky Health.  “Unlike generic products that are AB rated, interchangeable with the originator compound, biosimilars require both clinical testing and physician and patient education much like an innovator medication.”

About Makovsky + Company
Founded in 1979, Makovsky + Company (www.makovsky.com) is one of the nation’s leading independent global public relations and investor relations consultancies, focused in financial services, professional services, health care, technology, branding and investor relations.  The firm attributes its success to its original vision: that the Power of Specialized Thinking™ is the best way to build reputation, sales and fair valuation for a client. Based in New York City, the firm has agency partners in more than 20 countries and in 35 U.S. cities through IPREX (IPREX.com), the third largest worldwide public relations agency partnership, of which Makovsky is a founder.