Industry Trend Analysis - Amgen On Track To Take Lead In Cancer Biosimilar Market - JAN 2018

BMI View: Having already gained the first US approval for biosimilar bevacizumab, this step towards EU approval further cements Amgen ' s position as an early leader in the biosimilar market. Amgen, and its partner, Allergan, are on track to have the first marketed cancer biosimilar in both the US and EU, although legal wrangling has so far prevented a US launch. The impact on Roche is likely to be muted, however; the firm has anticipated eventual biosimilar competition across its portfolio and has taken steps to mitigate the effects.

The EMA's CHMP has adopted a positive opinion for the MAA of Amgen and Allergan's ABP 2015, a biosimilar version of Genentech ( Roche)'s Avastin (bevacizumab). The CHMP opinion will now be reviewed by the EC. If the MAA is approved, a centralised marketing authorisation will be granted that will be valid in the 28 members of the EU.

Amgen noted that this is the first time a bevacizumab biosimilar has been recommended for approval in the EU. In September 2017, ABP 215 became the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, to be approved by the FDA. It is approved in the US with the brand name Mvasi (bevacizumab-awwb). Amgen and Allergan are collaborating on the development and commercialisation of four oncology biosimilars. Amgen has a total of ten biosimilars in its portfolio, one of which has been approved by the EC.

ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix. The MAA for the biosimilar was based on a comprehensive data package that demonstrated ABP 215 and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase III trial in patients with non-squamous NSCLC.

Avastin Of Central Importance For Roche

Avastin is one of Roche's most profitable drugs; revenues reached USD6.9bn in FY2016. Although Mvasi has been approved in the US, it has not yet been launched there; Avastin's US patent is scheduled to expire in 2019, which has contributed to the delay in Mvasi's launch. The patent also gives Roche a chance to further solidify its position with Avastin, and ensuring brand loyalty will lessen the impact of Mvasi's eventual launch.

Roche achieved FY16 sales worth some CHF50bn (USD51bn), with pharmaceutical division sales reaching CHF39bn (USD39bn). Within this, sales of Avastin were worth CHF6,783mn (USD6,886mn), making the drug one of Roche's top sellers. This was up by 1.5% over the CHF6,684mn reported a year earlier. US sales continue to dominate, and were worth CHF2,964mn (USD3,009mn) in FY16, but were down by 3.1% over the CHF3,058mn reported a year earlier. European sales were slightly more positive, rising by 1.5%, from CHF1,813mn to CHF1,841mn (USD1,869mn). Although increasing, sales are showing evidence of slowing down.

Avastin Sales Slowing
Roche's Annual Avastin Sales (CHFmn)
Source: Roche, BMI

So far in FY17, sales of Avastin saw a decrease in Q317 compared to Q217, falling by 7.5% from CHF1,721mn to CHF1,592mn (USD1,654mn). Reflecting the situation at the end of FY16, US sales fell by 9.9%, from CHF751mn to CHF677mn (USD704mn), but European sales rose slightly, by 0.7%, from CHF435mn to CHF438mn (USD455mn). Compared to Q316, a fall in sales was more pronounced. Q317 total Avastin sales were down by 5.5% over the CHF1,684mn reported a year earlier; sales in the US fell by 6.4% and sales in Europe fell by 4.4%.

In the US, where Avastin is already broadly used in its approved indications, the fall in sales over Q316 was largely the result of increasing use of cancer immunotherapy medicines in lung cancer. Sales continued to grow in the International region, in particular in China, where sales increased because of broader market penetration in the lung and colorectal cancer settings. Sales in Europe were negatively affected by the removal of reimbursement for metastatic breast cancer in France.

Quarterly Avastin Sales In Decline
Roche's Quarterly Avastin Sales (CHFmn)
Source: Roche, BMI

The advent of biosimilar competition for Avastin will likely accelerate the decline in sales, but the full impact is questionable, as approved biosimilars are not necessarily substitutable for the biologic. Nonetheless, Roche has franchise protection strategies in place for its ageing drugs, and has follow-on compounds approved and in trials to take market share from its older drugs. In addition, the company has consistently gained approvals for new compounds, with these gaining traction as the portfolio begins to face declining revenues. Roche also has a rich pipeline with novel technologies that will be able to reduce the target market for older generation drugs. This will limit the impact of biosimilar competition on Roche's overall portfolio.