Deleted Tweets From Scott Gottlieb, R-D.C.

Until recently, biologics lacked this sort of competition. To market their product, sponsors submit a biologics license application (BLA) under the Public Health Service Act (PHSA). The PHSA had no abbreviated pathway to market for biologics prior to 2010 https://t.co/ruat5gnpOa.

To speed competition we issued a Biosimilars Action Plan in July to improve product development and approval process efficiency; increase scientific & reg. clarity; provide addt’l communications and outreach & address brand co. “gaming” of FDA requirements https://t.co/4g2yZDke1L https://t.co/EN8Qxa5PAr

The biosimilar pathway allows applicants that meet approval requirements to rely on FDA’s finding of safety, purity & potency for the biological reference product. As a result, it is generally less costly to develop a biosimilar https://t.co/lo67mXzpDJ.

The Biologics Price Competition & Innovation Act of 2009 (BPCIA) created an abbreviated pathway for biological products that are biosimilar or interchangeable to an FDA-approved reference product. https://t.co/Hvu3LgNYmF. https://t.co/nLMYZvGZnw

While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. This is especially true after 2 or more biosimilars are approved and on the market.

Since the BPCIA became law, we’ve approved 16 products including a record 8 in the last year https://t.co/8ymjFnVIFt and there are currently more than 60 biosimilar development programs underway. But only a fraction of the biosimilars approved by the FDA have launched. https://t.co/RvSAcDoG9r

Some biologics – including insulin - have historically been approved under the drug pathway. The BPCIA requires that these approved products will be deemed to be licensed under the PHSA on March 23, 2020. The guidances out last week describe how we plan to go about doing so. https://t.co/zzUMPK0hCw

Last week we announced additional steps including a draft Q&A regarding companies that use and sometimes abuse limited distribution systems to delay or derail an applicant’s access to reference product samples needed for testing to support an application https://t.co/lDCp8zTpBz.

And, in what I believe is a watershed moment for insulin products and for people with Type 1 diabetes, we issued two guidance documents outlining how we plan to transition insulin from a drug approval pathway to a biologics approval pathway. Let me explain. https://t.co/BGiDmOXvHR

To speed competition, we issued a Biosimilars Action Plan in July to improve product development & approval process efficiency; increase scientific & reg. clarity; provide addt’l communications & outreach & address brand co. “gaming” of FDA requirements. https://t.co/4g2yZDke1L https://t.co/2vi2H84RPL

I say this is a watershed moment because once insulin products are deemed to be licensed under the PHSA, products that are biosimilar to, or interchangeable with, these insulins can then come to market.

But once an insulin product is approved and available as an interchangeable under the PHSA, it may be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients. https://t.co/Di2ja3vcwN

Today there are no approved generic insulin products that can be substituted at the pharmacy, in part because it is hard to bring a substitutable insulin to market under the conventional drug pathway.

Interchangeables are biosimilars that meet additional requirements including that they can be expected to produce the same clinical result as the reference product in any given patient. Therefore, they may be substituted at the pharmacy level. https://t.co/l3bjBtvRjw https://t.co/O2ksBsEJsw

Access to affordable insulin is a matter of life & death for the 7 million diabetics who require daily insulin injections to maintain their blood glucose level. https://t.co/ujPB7aSPOD And yet the average list price has increased by 15%-17% per year from 2012-2016. https://t.co/k0HK8DwLog

The fact is, limited competition keeps insulin prices artificially high – three companies control 90% of the global market and produce all of the insulin used in the U.S., according to the Congressional Research Service. https://t.co/W2XDn5v3xY https://t.co/JT7kkJIufA

We’ve heard frequent reports of patients rationing insulin and, in some cases, dying because they can’t afford the injections. These tragic stories aren’t isolated occurrences and they’re not acceptable for a drug that’s nearly a century old.

We’re at a crucial stage in developing a competitive market for biological products. As you’ve seen, FDA is committed to making the development of biosimilars and interchangeable products more efficient. These changes are long overdue. https://t.co/bRPSZqyMyT

You can’t pin high prices on manufacturing challenges. Initially, insulin was made with great difficulty & expense from cow & pig pancreas cells after its discovery in 1921. But since the 1980s, recombinant DNA technology has allowed for efficient production from microorganisms. https://t.co/v0ArV4O68s

Given our long experience regulating insulin products and the high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident an interchangeable insulin will be attainable after the transition in March 2020.

Until recently, biologics lacked this sort of competition. To market their product, sponsors submit a biologics license application (BLA) under the Public Health Service Act (PHSA). The PHSA had no abbreviated pathway to market for biologics prior to 2010 https://t.co/ruat5gnpOa.

To speed competition we issued a Biosimilars Action Plan in July to improve product development and approval process efficiency; increase scientific & reg. clarity; provide addt’l communications and outreach & address brand co. “gaming” of FDA requirements https://t.co/4g2yZDke1L https://t.co/EN8Qxa5PAr

The biosimilar pathway allows applicants that meet approval requirements to rely on FDA’s finding of safety, purity & potency for the biological reference product. As a result, it is generally less costly to develop a biosimilar https://t.co/lo67mXzpDJ.

The Biologics Price Competition & Innovation Act of 2009 (BPCIA) created an abbreviated pathway for biological products that are biosimilar or interchangeable to an FDA-approved reference product. https://t.co/Hvu3LgNYmF. https://t.co/nLMYZvGZnw

While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. This is especially true after 2 or more biosimilars are approved and on the market.

Since the BPCIA became law, we’ve approved 16 products including a record 8 in the last year https://t.co/8ymjFnVIFt and there are currently more than 60 biosimilar development programs underway. But only a fraction of the biosimilars approved by the FDA have launched. https://t.co/RvSAcDoG9r

Some biologics – including insulin - have historically been approved under the drug pathway. The BPCIA requires that these approved products will be deemed to be licensed under the PHSA on March 23, 2020. The guidances out last week describe how we plan to go about doing so. https://t.co/zzUMPK0hCw

Last week we announced additional steps including a draft Q&A regarding companies that use and sometimes abuse limited distribution systems to delay or derail an applicant’s access to reference product samples needed for testing to support an application https://t.co/lDCp8zTpBz.

And, in what I believe is a watershed moment for insulin products and for people with Type 1 diabetes, we issued two guidance documents outlining how we plan to transition insulin from a drug approval pathway to a biologics approval pathway. Let me explain. https://t.co/BGiDmOXvHR

To speed competition, we issued a Biosimilars Action Plan in July to improve product development & approval process efficiency; increase scientific & reg. clarity; provide addt’l communications & outreach & address brand co. “gaming” of FDA requirements. https://t.co/4g2yZDke1L https://t.co/2vi2H84RPL

I say this is a watershed moment because once insulin products are deemed to be licensed under the PHSA, products that are biosimilar to, or interchangeable with, these insulins can then come to market.

But once an insulin product is approved and available as an interchangeable under the PHSA, it may be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients. https://t.co/Di2ja3vcwN

Today there are no approved generic insulin products that can be substituted at the pharmacy, in part because it is hard to bring a substitutable insulin to market under the conventional drug pathway.

Interchangeables are biosimilars that meet additional requirements including that they can be expected to produce the same clinical result as the reference product in any given patient. Therefore, they may be substituted at the pharmacy level. https://t.co/l3bjBtvRjw https://t.co/O2ksBsEJsw

Access to affordable insulin is a matter of life & death for the 7 million diabetics who require daily insulin injections to maintain their blood glucose level. https://t.co/ujPB7aSPOD And yet the average list price has increased by 15%-17% per year from 2012-2016. https://t.co/k0HK8DwLog

The fact is, limited competition keeps insulin prices artificially high – three companies control 90% of the global market and produce all of the insulin used in the U.S., according to the Congressional Research Service. https://t.co/W2XDn5v3xY https://t.co/JT7kkJIufA

We’ve heard frequent reports of patients rationing insulin and, in some cases, dying because they can’t afford the injections. These tragic stories aren’t isolated occurrences and they’re not acceptable for a drug that’s nearly a century old.

We’re at a crucial stage in developing a competitive market for biological products. As you’ve seen, FDA is committed to making the development of biosimilars and interchangeable products more efficient. These changes are long overdue. https://t.co/bRPSZqyMyT

You can’t pin high prices on manufacturing challenges. Initially, insulin was made with great difficulty & expense from cow & pig pancreas cells after its discovery in 1921. But since the 1980s, recombinant DNA technology has allowed for efficient production from microorganisms. https://t.co/v0ArV4O68s

Given our long experience regulating insulin products and the high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident an interchangeable insulin will be attainable after the transition in March 2020.