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Track 24: Biosimilars

What is a Biosimilar?

A biosimilar medication is one that is comparable to another biologic medication that has already been given approval. It is also frequently referred to as a "follow-on biologic," "subsequent-entry biologic," or "follow-on protein product" (including vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues and recombinant therapeutic proteins).

Both biologics and biosimilars can be made of sugars, proteins, nucleic acids, or complex combinations of these elements; they can also be made of living things like cells and tissues, as noted by the US Food and Drug Administration (FDA). They are isolated from a variety of natural sources, including human, animal, and microorganism sources.

A biosimilar cannot deviate significantly from the biologic it is mimicking and is already permitted in the US and EU, the two markets for biosimilars that have seen the most growth thus far (that already authorised product is known as the reference product in the US).

Companies must conduct studies demonstrating that the biosimilar is comparable to the reference biologic and does not significantly deviate from the reference drug in terms of quality, safety, or efficacy in both markets.

The amount of safety and efficacy data required to obtain approval for a biosimilar is typically less than that required to authorise the original biologic, as noted by the European Medicines Agency (EMA), because data on a biosimilar's reference biologic and how it is used and manufactured are already available.

Why are Biosimilars Different From Generics?

Generic drugs and biosimilar drugs differ not only in size, stability, and characterisation, but also in production process, long-term behaviour, and mode of action.

While some media outlets refer to biosimilars as "copycats" or "knockoffs," such euphemisms can oversimplify what is actually being developed. There has been much debate regarding the comparisons between generics (which must be identical to their reference products) and biosimilars (which have a natural degree of variability, similar to all different lots of the same biologic).

Because the molecules used as the active substances in biologics and biosimilars are either large (which, for generics, means they are synthesised through chemical reactions between different organic and/or inorganic compounds) or small (which, for biologics, means they are synthesised by different organic and/or inorganic compounds), the terms "biologics" and "biosimilars" are frequently used in the pharmaceutical and biotech industries (meaning they are composed of more than 1,000 amino acids and can be produced via modified cells of microorganisms, such as bacteria, yeast or in mammalian cell lines).

A nice illustration of the distinctions between a generic and biosimilar is provided by the Generics and Biosimilars Initiative (GaBI): A dalton is the standard unit used to express mass on an atomic or molecular scale, and an aspirin, a tiny molecule medicine, has just 180 of them. That aspirin has a constrained capacity to elicit an immunological response (the mechanism by which the body detects and protects itself against substances that seem foreign and dangerous), and that this capacity is largely consistent over time. A biosimilar, which can be either a cell signalling protein or a monoclonal antibody, weighs 150,000 daltons, has 20,000 atoms, degrades over time, and can cause a large immunological response.

The Biotechnology Innovation Organization observes that there are significant distinctions between producers of generic and biosimilar products. While a small molecule manufacturer can change the manufacturing process significantly and analyse the finished product to confirm that it is the same as before the manufacturing change, biologic and biosimilars manufacturers must ensure consistency, quality, and purity by ensuring that the manufacturing process remains largely the same over time.

The cost of any particular biosimilar is typically higher than the cost of a generic because of the complexity of biosimilars and the challenge of manufacturing them. The cost between biosimilars and their reference products (biosimilars in the EU have typically been 15–30% less expensive) may never be as great as the cost between generics and their reference products, despite the fact that more biosimilars are entering the market and increasing competition for expensive biologics.

Nevertheless, according to IMS, the introduction of biosimilars is having a significant impact in several EU nations (although the cost savings could not be apparent in the US until interchangeable biosimilars are available; see more in the Interchangeability section below).

What Biosimilars are Approved and Where?

A biosimilar can be filed two years after the reference biologic has been approved by the FDA in the EU, which is the trend-setter, whereas in the US, a biosimilar can be filed four years after the reference biologic has been approved by the FDA. More than 20 biosimilars were approved between December 2006 and January 2018 in the EU:

Are biosimilars the same as generic drugs?

Most likely, you have heard about generic medications. An identical version of a brand-name medicine is a generic version. Drugs sold under generic names function and can be used in the same manner as those sold under brand names. In other words, a generic medication can be used to treat the same ailment and is an equal substitute for its brand-name medication.

There are significant distinctions between a biosimilar and a generic biologic medicine, yet they are somewhat comparable. A biosimilar, for instance, is not an identical replica of the brand-name medication, unlike a generic drug.

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Here are some similarities between biosimilar and generic medications:

In studies, both are evaluated and contrasted with a name-brand medication.

The US Food and Drug Administration has previously authorised the brand-name medications that they are tested against (FDA).

Compared to the FDA review procedure for their brand-name medications, both undergo a rigorous but accelerated evaluation.

Both are equally secure and efficient as the branded medications.

Both might be more affordable as treatments than the corresponding name-brand medications.

Here are some distinctions between biosimilar and generic medications:

A generic medication is created using chemicals, while a biosimilar is created from a biologic (natural) source.

A generic medication is a perfect chemical replica of its brand-name biologic counterpart, but a biosimilar is similar to it in many respects.

Research comparing a biosimilar to its original biologic frequently provide the FDA with more data than studies on generic drugs do. The reason for this is that a biosimilar cannot be produced exactly like its brand-name biologic because it is derived from a natural source.

Generic medications and biosimilars follow separate processes to receive FDA approval.

While a generic drug can be readily swapped for its brand name counterpart, a biosimilar requires additional clearance after it has been approved in order to be considered interchangeable with its brand name biologic.

All of these variations are a result of how biologics (and biosimilars) are created in laboratories from a natural source (a living system such as yeast, bacteria, or animal cells).

A biosimilar has a biologic (natural) source

A generic drug is a perfect replica of the brand-name medication (that is, it has the exact same chemical makeup). This is achievable because medications' active components are created from compounds that have a repeatable structure.

A biologic, on the other hand, derives from a biological (natural) source and cannot be precisely duplicated. These medications originate from extremely intricate biological systems with variable settings. Therefore, even though a biosimilar is close in the most significant areas, it cannot have a perfect structural match. While not an identical replica of the brand-name medication, a biosimilar is quite similar to it.

How safe are biosimilars?

Before being used to treat an illness, a biosimilar must undergo clinical testing and FDA approval, just like other medications. The biosimilar and its original biologic, which was created initially, are contrasted in clinical trials. The original biologic is a well-known medication that has undergone clinical testing, been approved, and is now being used to treat a condition. The biosimilar's safety and efficacy in treating the same disease as the branded biologic must subsequently be evaluated in clinical trials.

What is the purpose of creating biosimilars?

Because they are expensive to study and produce, biologics are frequently quite expensive. And unlike medicines, where the availability of generic versions can enhance competition and drive down pricing, there were no alternative forms of biologics up until quite recently.

Even when biologics are the best treatment for a condition, access to them can occasionally be difficult due to their high price. The Biologics Price Competition and Innovation Act was passed by Congress to lower the cost of biologic medications and increase its accessibility to more people (BPCIA). The FDA was able to shorten the approval procedure for biosimilars because to this statute.