New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed. Early this week, Teva announced it will be acquiring Allergan’s generics unit for $40.5 billion. This move comes just a few short days after an independent Dutch foundation connected to Mylan bought 50 percent of Mylan’s total issued and outstanding capital. In doing so, the foundation effectively gained control of half of Mylan and the ability to protect “stakeholder interests”— in other words, halting Teva in its takeover attempts.
The acquisition of Allergan’s generic division, which brought in $8.4 billion in sales last year, could end up giving Teva more than a boost in just the generics market — it could help advance the company’s presence in the biosimilars space. In 2011, Allergan (formerly Actavis) — then known as Watson Pharmaceuticals — joined forces with Amgen on the development of four oncology biosimilar candidates. Following the acquisition of the generics unit, Teva could be transferred the rights to the partnership, Bloomberg Business reported.
According to Teva’s website, the company has “adopted a selective approach to developing biosimilars.” Back in July, the company mutually ended a partnership with Lonza due to the unanticipated high costs of clinical development. At the time, Michael Hayden, Teva’s president of global R&D and CSO, told BioPharma-Reporter, “We are looking to both grow organically, but also look at inorganic growth in terms of potential partners in the space.” According to Hayden, the company was turning its focus to biologics facing expiration post-2020 following the successful submission of several protein-based biosimilar Biologics License Applications (BLAs) to the FDA. While the biosimilars under investigation for biologics expiring post 2020 still have a ways to go, the company was seeking partners and planning on some in-house development to tackle some of the sooner-to-expire biologics, such as Rituxan and Humira, Hayden said.
Whatever results from these partnerships, Teva already has one biosimilar — or what it has called a biosimilar — approved in the U.S., long before the Sandoz biosimilar of filgrastim won the acclaim of being first to market. The biosimilar, known as tbo-filgrastim (brand name Granix) — a copy of Amgen’s Neupogen (filgrastim) — was approved by the FDA in 2012 and launched onto the market in November 2013. However, unlike Sandoz’s product which was approved using the newly established biosimilar pathway, Teva’s biosimilar was approved using the BLA process, meaning in the regulatory sense, it was not strictly known as a biosimilar in the U.S., Pharma & MedTech Business Intelligence reported. Because of this, the drug was required to be tested on its own and not in reference to Amgen’s Neupogen, even though it contained the same active ingredient (granulocyte-colony stimulating factor, or G-CSF) and was already being marketed as a biosimilar in the EU. With all the concern about biosimilars destroying sales of off-patent biologics, the sales of Granix are yet another indication that this market could end up being different than the generics market. According to the website for the treatment, within its first 17 months on the market, Granix earned greater than 34 percent of the G-CSF market. It’s not an insignificant percentage — but it’s certainly not a huge percentage either.
In other biosimilar news, AstraZeneca also threw its hat into the cancer biosimilar ring this week by teaming up with Fujifilm Kyowa Kirin Biologics (FKB). The goal of the $45 million partnership is to jointly develop a biosimilar version of Roche’s Avastin targeting various solid tumor types. The treatment, FKB238, entered into Phase 1 clinical trials in Europe last November, and has captured AstraZeneca’s attention as a potential candidate to include in drug cocktails for cancer — a move which could lower escalating cancer treatment costs.
One AstraZeneca spokeswoman told Reuters that the partnership “supports our combination-focused strategy in oncology to help explore potential new treatment options, while keeping the cost of new therapies low enough to enable access for patients and payers.” In particular, the British company has goals of exploring FKB238 in combination with MEDI3476 and some of its other immunotherapy candidates.
AstraZeneca has been eying the biosimilar market since early 2013. The company has even gone so far as to voice its interest in acquiring South Korea’s Celltrion, though this has yet to happen, and the company could face competition from the likes of Roche and Teva. This newest partnership is a good indication there could be more biosimilar efforts in the company’s future, especially seeing its focus on and capacity for manufacturing biologics.