¿Cómo se preparan biosimilares? – HealthyWomen

Many people struggling with difficult-to-manage chronic medical disorders have found relief with biopharmaceuticals. You could be taking a biopharmaceutical without knowing it. Some common biodrug names you may have heard are adalimumab (brand name: Humira), infliximab (brand name: Remicade), and trastuzumab (brand name: Herceptin).

Biopharmaceuticals may be useful for a wide range of medical 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 up to $30,000 a year.

For some people who use biopharmaceuticals, there may be an equally effective alternative, biosimilars. Knowing how biosimilars are prepared can be helpful in understanding if they could be an option for you.

Preparation of biopharmaceuticals and biosimilars

Unlike most drugs that are prepared from chemicals, biopharmaceuticals are made from living material such as animal cells, fungi, and bacteria. Consequently, this process to prepare a biopharmaceutical is complicated, long and expensive. A simple medicine, such as aspirin, might be made of only 21 atoms, while a biopharmaceutical may have more than 25,000.

To create a biopharmaceutical, living cells with special designs are grown in facilities under very specific and carefully controlled conditions. Culturing these cells can take weeks, during which these cells are closely monitored.

After the cells are grown, scientists remove a protein from them that will be used to make the biodrug. This protein is purified until the final biodrug is obtained.

Biosimilars are biological medicines that are also prepared from living tissues and that are designed based on a pre-existing biopharmaceutical (called reference product), their preparation process requires less interaction. This often keeps the cost lower.

“I felt the arrival of biosimilars in 2015 with the introduction of Zarxio [filgrastim]which is useful for people to fight infections while receiving chemotherapy,” said Lisa Kennedy Sheldon, Ph.D., an international nursing consultant and professional oncology nurse. “We in cancer care settings were the first to feel the impact of what was then a new method of making drugs.”

FDA approval of biosimilars

FDA approval of biosimilars

Despite the lower cost of biosimilars, they have the same efficacy and safety as biopharmaceuticals. To create new biosimilar assays, companies carefully compare and compare scientific information to develop products that meet the FDA’s high standards, which are the same standards a reference product must meet before approval.

“Biological drugs, whether originator products or biosimilars, have a different type of approval process than brand-name or generic drugs that are made with chemicals,” Sheldon said. “The FDA evaluates them differently when considering approval in terms of their safety, how well they work, their potency or effectiveness, and their purity.”

Biosimilars must to try on many times to demonstrate that they work exactly as the original biopharmaceuticals (reference products) on which their design was based, and with the same safety, before the FDA can approve them.

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

Patent Disagreements Related to Biosimilars

Patent Disagreements Related to Biosimilars

The patent process partially explains why there are so few biosimilars on the market. Companies that make biopharmaceuticals often patent their drugs for a specific number of years, and companies that make biosimilars must wait for those patents to expire before their versions can be approved.

Thanks to the Biopharmaceutical Price Competition and Innovation Act (BPCIA)2009 included in the Affordable Care Act, companies that make biosimilars have an expedited approval process based on similarities to reference biologics. They do this by filling out an application known as a summary biological license application (aBLA).

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

To avoid this, manufacturers of biosimilars that submit aBLA have the option of participating in a process called patent evaluation which determines which disputes are relevant and resolves them.

Even with these legal proceedings, companies that manufacture biosimilars in the United States still face challenges from biopharmaceutical manufacturers. This may partially explain why biosimilars are not widely used in the US as they are in other countries, despite their Increasing demand.

Are biosimilars an option for you?

Are biosimilars an option for you?

Biopharmaceuticals can be useful for a variety of medical conditions, but they are often expensive. If you live with a medical condition that can be managed with biopharmaceuticals, biosimilars may be a cheaper (and just as effective) alternative.

“Over the last nine years, you’ve seen biosimilars increasingly used in clinical practice for all types of disorders, from diabetes to psoriatic arthritis and now even some forms of breast and colon cancer,” Sheldon said. “I think patients and medical providers should have a level of comfort and acceptance that this process is necessary to reduce some medical costs without sacrificing benefits for patients.”

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