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Betting on Biosimilars

A Polish pharmaceutical company scales up to meet the demand in a burgeoning market

Just as generic versions of small-molecule drugs have helped to reduce healthcare costs, biosimilars offer an alternative to the class of medications known as biologics. Unlike small-molecule drugs, which are derived from chemicals, biologics are produced from living cells. Generic-like versions of biologics are called biosimilars because they work like their patented counterparts, but—unlike generics—can have small structural differences. Over the next decade, biosimilar drugs may well provide substantial price and market competition for biologics, which made up a US$170 billion industry in 2013 and ranked among the world’s most profitable drugs.

Many biologic drugs will soon lose patent protection in Europe and the United States, opening the door to manufacturers poised to bring biosimilar versions to market. Europe has been at the forefront of the biosimilar industry, adopting a regulatory framework in 2005. The European Medicines Agency (EMA) has approved 20 biosimilars, and the U.S. Food and Drug Administration approved its first biosimilar product, a version of the white blood cell–boosting filgrastim, in March 2015.

Looking to capture the biosimilars market in Eastern Europe, Polpharma, Poland’s largest manufacturer of generic pharmaceuticals, has invested in an R&D laboratory and facility capable of manufacturing clinical-grade biosimilar drugs. Located in the Gdansk Science and Technology Park, Polpharma’s biologic unit hopes to register four or five biosimilar drugs with the EMA in the next few years, according to Klaus Martin, the company’s head of biologics. “Like generics, biosimilars are very important to rein in healthcare spending and allow wider access to drugs,” he says. Currently, the firm has a proprietary portfolio, but Martin says at least some are monoclonal antibody drugs that will soon be coming off patent. “I’m quite confident that Polpharma can deliver quite a cost-competitive set-up,” he says. “If you look at originator drugs, many of these use technologies that were available 10, 15, 20 years ago. The cell lines they used years ago were nowhere near as productive as modern systems.” 

The first biologics manufacturing facilities relied on large, dedicated fermenters and fixed stainless steel pipes that required time-consuming and expensive work stoppages to clean and maintain. In contrast, modern cell-line technology uses smaller-batch, flexible systems with sterile, single-use disposable fermentation bags. The single-use bags are incinerated onsite, says Martin, and even help generate electricity at the Gdansk plant, further reducing costs. Production can be scaled up quickly by operating fermenters in parallel. He adds that very few pharmaceutical companies have bothered to re-engineer their cell lines to achieve higher productivity with existing biologic drugs, because doing so would entail new rounds of expensive clinical trials to show biosimilarity to their earlier production lines.

In addition, lower upfront costs allow Polpharma to produce these medicines at a reduced price, which should offer further financial relief for patients and healthcare providers worldwide.

Illustration by Nicolet Schenck

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