To Be Exclusive or Not: How Will Biologics Be Impacted by the Trans-Pacific Partnership?

Biologics Manufacturing

A compromise reached under the Trans-Pacific Partnership will change the rules determining the exclusivity periods for biologics. How will this affect the U.S. market?
Image source: Flickr CC user NVinacco

After seven years of intensive negotiations, terms of the Trans-Pacific Partnership (TPP) were finally reached in early October. A trade agreement between twelve Pacific Rim countries, the TPP seeks to promote economic growth and covers all industries, including those dealing with the life sciences. While intended for collective gain, the deal has caused some consternation within the innovative field of biologics. In fact, it’s been speculated that reaching accord on the provisions governing the intellectual property protection of biopharmaceuticals contributed to delays in reaching a final agreement.1 But now that a compromise has been reached, what does this mean for the nations involved—and in particular, the United States?

The Long and Short of It: Exclusivity Periods of Biologics under the TPP

The biggest change wrought by the TPP relates to exclusivity periods. Currently, U.S. biologics firms enjoy a twelve-year combined data and market exclusivity period for their products and had been hoping to institute a similar provision in the trade agreement. Unfortunately, even though some nations like Japan supported the longer terms championed by the U.S., many others did not. Australia and New Zealand, for example, preferred terms as short as five years. In the end, both sides agreed on an option that ultimately amounts to an eight-year exclusivity term.

While the provisions may not change much for how firms treat the data exclusivity period in the U.S., concerns remain for how the TPP agreement will affect global innovation.2 Most new biopharmaceuticals are developed by U.S. companies.3 Even though the TPP allows a data exclusivity period similar to what’s presently in existence in the United States, the market exclusivity term is significantly shorter. As a result, biosimilars—products that are similar to an already existing biologic—can be released on to the market much sooner.

To governments, healthcare providers and consumers, the availability of biosimilars can be viewed as a boon. It offers them more choices and makes such therapies more affordable. To biologics firms, however, readily available biosimilars complicate the market and remove incentives that encourage laboratories to pursue potential candidates. Why develop treatments when revenue could be lost to cheaper versions within only a few years? Instead, companies might decide to concentrate on therapies that would see a profit for a longer duration.

U.S. Biologics Firm Can Withstand the Pressure of Shorter Exclusivity Periods by Focusing on Quality

The shorter terms certainly put the U.S. life sciences industry at a disadvantage. However, the economic threat posed by biosimilar development and availability does not mean firms need to slow down innovation. Indeed, by emphasizing the quality of reference products, companies can withstand the added pressure and even emerge ahead of the field.

Let’s consider the lack of regulatory clarity regarding biosimilars in the U.S. One of the repercussions is that people remain skeptical about the safety of “generic” biologics. Original biologics manufacturers can take advantage of this uncertainty by emphasizing the sustained quality of their biotherapeutics. Because biosimilars are not exact replicas of their reference products in the same way that traditional generics are of small-molecule drugs, patients are often leery of any potential unexpected side effects. Ensuring that original biological therapies are of high quality will help fuel the perception that they are superior to biosimilars.

Another way for original biologics manufacturers to remain competitive is to improve the performance of first-generation biologics. Creating a new biotherapeutic from scratch can take years and cost millions of dollars. Developing the second-generation of an existing product requires far fewer resources. In fact, relatively simple tweaks like better formulations, more efficient methods of administration and new indications can extend the data exclusivity period under the TPP, which would protect companies from the encroachment of competing biosimilar products.

In addition to maintaining the public perception of biologics and improving existing products, implementing effective manufacturing strategies offer other benefits. Due to the resources required to minimize compliance risks, quality management can make up a large portion of a company’s overhead. But by streamlining processes, organizations can minimize costs and maximize productivity. These two items may seem contradictory, but that need not be the case. Adopting automated alerts, for instance, would reduce hours devoted to repetitive, non-productive tasks. Once the TPP goes into effect, life sciences firms will need to utilize this, and similar, strategies in order to remain competitive in the global market.

The BIOVIA Biologics Manufacturing Solution is an integrated digital solution that supports life sciences organizations in their efforts to manufacture high-quality biotherapeutic products. As the provisions laid out by the TPP are finalized in the coming months, biologics firms will need to find ways to remain competitive against cheaper biosimilar products. No matter which avenue they pursue, a common foundation rests in emphasizing quality in the original biologic from the beginning of the R&D process until market release and beyond. The Biologics Manufacturing solution enables companies to accomplish these goals by improving bioprocess design and performance, and supporting collaboration between departments. If your company would like to boost its culture of production and quality excellent to thrive in an increasingly difficult market, please contact us today to learn more the BIOVIA Biologics Manufacturing solution.

  1. “U.S., Australia Agree on Complicated Compromise on Biologic Drugs,” October 4, 2015,
  2. “Trans-Pacific Partnership and the Continuing Controversy Over the Exclusivity Period for Biologics,” November 22, 2015,
  3. “TPP provides challenges, opportunities for life sciences companies,” November 25, 2015,

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