Understanding the Evolving Biopharmaceutical Landscape

With biosimilars being an everyday headline, Jason Bernstein, Epocrates Lead Strategist, outlined key reasons for pharma's growing interest in biosimilar development and key differences between generics and biosimilars.

The biopharmaceutical landscape has evolved greatly over the past few years, and it has been estimated that biosimilar drugs may reduce US health spending by $54 billion over the next decade.

“In the news, biosimilars have become an everyday headline,” said Jason Bernstein, Epocrates Lead Strategist, in his webinar presentation “Biosimilars: Key Insights on the Evolving Biopharmaceutical Landscape.”

Bernstein outlined 3 reasons why there has been a growing interest in biosimilar development by the pharma industry.

First, the specialty pharma industry is on the cusp of one of the largest growth periods in history. In 2009, specialty drugs represented 20% of all drug costs. By 2018 specialty drugs are expected to make up 50% of overall drug costs for commercially insured individuals. In 2008, 25% of all drugs approved by the FDA were specialty drugs. Now, more than 50% of all drugs being approved are specialty drugs, and more than 900 biologics are in various stages of development.

Second, with the loss of key patents, such as Crestor, Lipitor, and Plavix, there is greater pressure on individual companies to strengthen their research and development pipelines. With the rise in biologic use and acceptance and ongoing patent expirations in that space, biosimilars seem like an obvious choice.

Lastly, unlike generics, biosimilars need to be marketed as branded drugs, so there are opportunities to give second life to biologics and improve pipelines.

In order to fully understand the impact of biosimilars, which are generics of biologics, we must first dig deeper into what biologics are, Bernstein said. Just 7 years ago there were no biologics in the top 10 list of best selling drugs by revenue. Today, 9 out of the 10 top selling drugs in the world are biologics.

Biologics are large molecule drugs produced from living cells. They’re produced through recombinant DNA, which involves splicing DNA into a living cell. The cell reproduces, undergoes complex purification in a highly controlled environment, and it becomes a biologic medicine.

There is often a misconception that biosimilars are the same thing as generics, but there several key differences. Generics are copies of the same chemical compounds to produce identical molecules. Meanwhile, biosimilars are the reproduction of a DNA sequence in living cells. A pharmacist can recommend a generic in place of a branded small molecule drug as long as they have the same compound, but there are currently no biosimilars on the market that is interchangeable with a biologic. However, there are expected to be interchangeable biosimilars reaching the market within the next 2 years.

Given the complexity around biologics, education is crucial, said Bernstein. The key aim for education campaigns is for healthcare providers to be confident prescribing biosimilars as a viable alternative to the original biologic.

However, there is another side to the story, according to an article from Genentech. Biosimilars go through an abbreviated regulatory pathway, so they usually get approval based upon less comprehensive data sets compared to the original medicines. Because of this, it is important to closely monitor biosimilar experience in clinical practice in the years ahead to ensure patient safety and benefit. Also, because biosimilars are not exact copies of the original medicine, patients and their doctors have a right to know exactly what medicine the patient is receiving.

Right now, major biopharmaceutical firms are in the midst of a fierce battle to get biosimilars to market, and major activities are coming out from Amgen, Sandoz, and Pfizer.