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FDA releases new information on interchangeable biologicals Posted 24/04/2020

The US Food and Drug Administration (FDA) has released new information on its website, clarifying the difference between biosimilars and interchangeable biologicals and says it will make more treatment options available to more people.

FDA has recently issued a raft of changes related to biosimilars, including providing a new definition of the term ‘biological product’ (which will transition around 100 products from new drug applications to biological license applications) [1]. The agency has also released draft guidance on licensing biosimilars for only some of the approved indications of the originator [2] and on labelling and advertising biologicals and biosimilars [3].

The agency has now issued public information on the difference between biosimilar and interchangeable biological medications, which begins by defining biologicals as ‘medicines that come from living organisms’. It also states that, because of this, manufacturing them can be more complicated than chemical drugs.

A biosimilar is defined by FDA as ‘a biologic[al] that is highly similar to, and has no clinically meaningful differences from, another biologic[al] that’s already approved by the FDA’ and is said to have the same strength and side effects as the reference drug. The information goes on to reassure people that biosimilars are just as safe and effective as the originator biological.

FDA defines an interchangeable product as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’.

There are currently no biosimilars approved by FDA as interchangeable, but when they do become approved, pharmacists will be able to substitute them without the approval of the prescriber (similar to generics).

Notably, this will also apply to insulin products, which are being transitioned from approval under the Federal Food, Drug, and Cosmetic Act to being licensed as biologicals under the Public Health Service Act [4].

FDA has recently come under criticism [5] from insulin makers Eli Lilly and Novo Nordisk after it published guidance [6] stating that immunogenicity testing may not be necessary for interchangeable insulin products, if a comparative analytical assessment demonstrates that the products are ‘highly similar’.

The same transition applies to human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin and menotropins.

The information closes by stating that interchangeable biologicals will improve competition in the biologicals market, giving patients more treatment options at potentially lower costs.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues new rule on definition of term ‘biological product; [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-new-rule-on-definition-of-term-biological-product
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on licensing biosimilars for fewer indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-new-rule-on-definition-of-term-biological-product
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on labelling and advertising of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-labelling-and-advertising-of-biologicals
4. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
5. GaBI Online - Generics and Biosimilars Initiative. Comments criticize FDA guidance on insulin biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/Comments-criticize-FDA-guidance-on-insulin-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for insulin biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-insulin-biosimilars

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Source: US FDA

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