Copaxone

(glatiramer acetate)

Updated 02.2017
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US Product Considerations

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Product is available on the wholesale level; however, large quantities will require approval by Teva. They also do not want the product to be shipped outside of the US. It is unknown as to whether or not Teva would approve a biosimilar trial, but they have approved supply for comparator trials with new molecules in the past.

There is a new 40 mg formulation (dosed 3 times per week, as opposed to daily) that is now starting to get attention for biosimilar research, although it is most likely only under preliminary analytical research at this time. As of now, the 40 mg formulation is only approved in the US.

Availability for different research phases:
  • Analytical – Myoderm has been able to get multiple lots for reference libraries (several lots available per month).
  • Phase I – Myoderm can purchase 50–100 packs from a single lot rather quickly (2 weeks).
  • Phase III – If a single lot is required, the only option is going direct to Teva. If multiple lots are acceptable, Myoderm can source 100–200 packs monthly, possibly more with advance notice.
Shelf life:
  • Typically 12–18 months from time of purchase. There is no difference in sourcing from suppliers versus direct from Teva, as stock turnover is high, so new lots are entering the market every few weeks.
Documentation:
  • COA may be available, especially if Teva has approved the supply. BSE statements, however, will not be available.
Pricing:
  • US product price is considerably higher than EU product, sometimes as much as double the cost.

EU Product Considerations

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Product is available in many local EU markets through authorized distributors. In some markets, like the UK and France, the product is a hospital-only line and is not available on the wholesale level.

It is unknown as to whether or not Teva will consider supply for biosimilar trials, but they have supported other clinical trials in the past. They will want to know the EudraCT number and list of countries for the study.

Availability for different research phases:
  • Analytical – Product is readily available and several lots per month can be accumulated by reaching out to multiple EU markets. Variation in lot turnover sometimes leads to variance in expiration dating, which could be helpful in building a reference library.
  • Phase I – Myoderm can purchase 50–100 packs from a single lot rather quickly (2–4 weeks).
  • Phase III – If a single lot is required, the only option is going direct to Teva. If multiple lots are acceptable, Myoderm can source 100–200 packs monthly, possibly more with advance notice.
Shelf life:
  • Typically 12–15 months from time of purchase.
Documentation:
  • COA is available in some local markets and would be supplied if purchased directly. BSE may be available if purchased direct from Teva.
Pricing:
  • Germany tends to be a more highly priced market than other EU markets.
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