Avastin

(bevacizumab)

Updated 08.2016
Print this content
download this content

US Product Considerations

- +

Genentech has restrictions on this product and it is not available through traditional wholesale pharmacy channels. The manufacturer has to approve a pharmacy before they can purchase the product for patients. Unless deals are struck with specialty wholesalers or oncology pharmacies, the product is very hard to acquire in the secondary market.

Genentech will consider supplying the product for biosimilar trials, and has supported trials previously. They will want to know the name of the sponsor and some general trial/protocol information. They will not supply product if it’s being shipped outside of the US.

Availability for different research phases:
  • Analytical – Myoderm has been able to get multiple lots for reference libraries (typically 2-4 lots available per month). Product has been sourced through specialty pharmacies and suppliers.
  • Phase I – Myoderm can purchase 50-100 vials from a single lot rather quickly (2 weeks) through specialty supplier contacts.
  • Phase III – If a single lot is required, the only option is going direct to Genentech. If multiple lots are acceptable, Myoderm can source 500-800 vials monthly, possibly more with advance notice.
Shelf life:
  • Typically 18-21 months from time of purchase. There is no difference in sourcing from suppliers versus direct from Genentech, as stock turnover is high, so new lots are entering the market every few weeks.
Documentation:
  • COA and BSE statements are not available whether purchasing through suppliers or direct from Genentech. Genentech will provide a batch release document if you purchase through them.
Pricing:
  • If not buying direct from Genentech, price will run 7-10% more.
  • US product price runs 25-40% more than EU product.

EU Product Considerations

- +

Product is available in many local EU markets through Roche authorized distributors. In some markets, like the UK and France, the product is a hospital-only line and not available on the wholesale level. In addition, Romania forbids the export of most oncology drugs, which has impacted the quantities available in the EU market in general. The 100-mg strength is more difficult to source than the 400-mg strength.

Roche will consider supplying the product for biosimilar trials, and has supported trials previously. They will want to know the EudraCT number and list of countries for the study. They will not supply product if it’s being used in the US or Japan.

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 vials from a single lot, but it is now taking longer than in the past (4-6 weeks).
  • Phase III – If a single lot of over 200 vials is needed, it will most likely require going direct to Roche. If multiple lots are acceptable, Myoderm can source 200-400 vials monthly by using multiple suppliers/markets, 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 Roche, as stock turnover is high, so new lots are entering the market every few weeks.
Documentation:
  • COA is always available. BSE is typically only available if purchased direct from Roche.
Pricing:
  • Germany is a higher priced market than other EU markets.
  • Buying direct from Roche is 20%-30% more expensive than buying from local EU markets.
Print this content
download this content