How Are Biosimilars Made? – HealthyWomen

Many people struggling with difficult-to-manage chronic health conditions have found relief with a type of medication called biologics. You may be taking a biologic and not even know it. Some common biologics you may have heard of are adalimumab (brand name: Humira), infliximab (brand name: Remicade), and trastuzumab (brand name: Herceptin).

Biologics may be helpful for a wide range of health problems, including:

  • Diabetes
  • Psoriasis
  • Colitis
  • Crohn’s disease
  • Multiple sclerosis
  • Arthritis
  • Breast, lung and colon cancers

They can also be very expensive. Humira, for example, can cost as much as $30,000 a year.

For some people who use biologics, there may be a less expensive but equally effective alternative: biosimilars. Knowing how biosimilars are made can help you understand if they may be an option for you.

Manufacturing of biological and biosimilar products

Unlike most medications, which are made from chemicals, biologics are made from living material such as animal cells, yeast, and bacteria. For this reason, the process of making a biological product is complicated, slow and expensive. A simple drug like aspirin may be made up of only 21 atoms, while a biological drug may contain more than 25,000.

To create a biologic, specially designed living cells are grown in a facility under very specific and strictly controlled conditions. The growth of these cells can take weeks, during which they are closely monitored.

Once the cells grow, scientists extract a protein from them that will be used to make the biologic. This protein is then purified into the final biological product.

Biosimilars are biological medicines that are also made from living tissue and are modeled after a pre-existing biological product (called a reference product); the creation process is less complicated. This often translates into lower cost.

“I first felt the arrival of biosimilars in 2015 with the introduction of Zarxio [filgrastim]”which helps people fight infections while they receive chemotherapy,” he said Lisa Kennedy Sheldon, Ph.D., global nurse consultant and oncology nurse practitioner. “We in cancer care were among the first to feel the impact of what was a completely new way of thinking about drug manufacturing.”

Obtain FDA approval for biosimilars

Obtain FDA approval for biosimilars

Despite the lower cost of biosimilars, they are as effective and safe as biologics. To create new biosimilars, companies carefully analyze and compare scientific information to develop a product that meets the FDA’s high standards—the same standards that a reference product must meet before it can be approved.

“Biological medications, whether the originator product or a biosimilar, have a different type of approval pathway than brand-name or generic pharmaceutical products that are made with chemicals,” Sheldon said. “The FDA looks at them differently when they approve them for safety, for how they work, for their potency or effectiveness, and for their purity.”

Biosimilars must be tried many times to demonstrate that they work in exactly the same way as the original biological products (reference products) that follow the model, and that they are equally safe, before they can be FDA approved.

The FDA continues to monitor the safety and effectiveness of biosimilars after their approval. This monitoring includes inspection of manufacturing facilities as well as review of manufacturer, supplier, and patient safety reports submitted to the FDA.

Patent Disagreements on Biosimilars

Patent Disagreements on Biosimilars

Part of the reason there are so few biosimilars on the market is because of the patent process. Companies that make biologics typically patent their drugs for several years, and biosimilar companies have to wait for those patents to expire before they can approve their versions.

Thanks to 2009 Biologics Price Competition and Innovation Act (BPCIA) Included in the Affordable Care Act, companies that make biosimilars can expedite approval of their products based on similarity to a reference biologic product. They do this by submitting an application known as an Abbreviated Biological License Application (aBLA).

But the BPCIA also says that filing an aBLA infringes certain patents related to the reference biologic, meaning the creator of the reference product can take legal action against the biosimilar company to block its approval.

To avoid this, biosimilar manufacturers that file an aBLA have the option of participating in a process called patent dance which determines which patent disputes are relevant and resolves them.

Even with these legal processes, companies manufacturing biosimilars in the United States still face many challenges from biologics manufacturers. This may be part of the reason why biosimilars are not used as widely in the US as in other countries, despite Increasing demand.

Are biosimilars an option for you?

Are biosimilars an option for you?

Biologics can be helpful for a variety of health conditions, but they often come with a high price tag. If you live with a health condition that can be managed with biologics, biosimilars may be a cheaper (and just as effective) alternative.

“Over the past nine years, I have seen increasing use of biosimilars in clinical practice for all types of conditions, from diabetes to psoriatic arthritis and now even some forms of breast and colon cancer,” Sheldon said. “I think patients and providers need to have a level of comfort and acceptance that this is a way forward to reduce some of the health care costs without sacrificing any of the benefits for patients.”

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