Updates on Some Lesser-Known Manufacturers’ Plans for Biosimilars in the US

Over the course of several years, BR&R has followed the progress of several smaller biopharmaceutical firms, each of which have (or had) plans to enter the US market. In this post, we update developments for several of these manufacturers below.

Tanvex Biopharma USA. When we first reported on Tanvex in October 2018, it had just submitted its first 351(k) application to the US Food and Drug Administration (FDA) for approval of TX01, a filgrastim biosimilar. The FDA issued a complete response letter on September 25, 2019, but this did not involve new clinical data, according to Tanvex. Furthermore, a patent suit for this product was settled with Amgen in December 2019, but terms were not disclosed.

In March 2020, Tanvex announced the completion of a phase 3 study for a trastuzumab biosimilar (TX05). This investigation was conducted in multiple countries outside of the US. A request for comment on Tanvex’s US plans for TX05 went unanswered.

Bio-Thera Solutions. This China-based manufacturer announced positive phase 3 trial results in Chinese patients for its lead biosimilar product BAT1706 (bevacizumab) in February 2020. Previously, a phase 1 study supported pharmacokinetic and pharmacodynamics similarity compared with both US- and EU-sourced Avastin®.

Bio-Thera expects plans for this bevacizumab biosimilar to progress rapidly: Bert Thomas, IV, PhD, MBA, Senior Vice President, Business Development, commented to BR&R via Email: “We do plan to file for approval of BAT1706 in the US. We expect to file the BLA with the FDA in Q4 of 2020.”

Bio-Thera Solutions also completed a phase 1 trial of its bio-better version of trastuzumab (BAT8001). This agent uses trastuzumab as the antibody component of the antibody-drug conjugate. Not considered a biosimilar, it would likely be filed as a 351(a) biologic rather than a 351(k) biosimilar.

Alteogen. Since our initial report in January 2018, Alteogen has made limited progress on its biosimilar versions of trastuzumab and ranibizumab. Alteogen’s phase 1 trial of ALT-02 (trastuzumab) tested the biosimilar against the EU- and US-sourced versions of Herceptin in 2017. A phase 1 trial of ALT-L9 (ranibizumab) was scheduled to start in October 2019, but no update of this investigation was available on the Alteogen website or on www.clinicaltrials.gov (last updated in September 2019).

In a press release dated May 22, 2019, Alteogen stated, “We will initiate the global Phase 3 clinical trial [of Eylea®] this year to build the foundation for entry into the global market including the US, Europe, and Japan upon the substance patents expiration in each of the countries.”

Archigen Biotech. In our post from July 2018, we indicated that Archigen Biotech was focused on advancing its rituximab biosimilar SAIT101. A phase 1 trial was completed demonstrating similarity between this agent and the US-sourced Rituxan® and EU-sourced MabThera® in patients with rheumatoid arthritis. Archigen’s phase 3 trial of SAIT101 was to include over 300 patients with follicular cancer, and use MabThera as the comparator. That investigation was scheduled to be concluded in May 2020.

Archigen Biotech is a joint venture between Astra Zeneca and Samsung BioLogics. We reached out to Archigen for an update, but they did not respond. Further information on the progress of the phase 3 trial is not available. We originally anticipated a potential filing in the fourth quarter of 2019, assuming completion of the phase 3 trial.

Lupin. According to a November 2019 report, Lupin plans to seek permission to bring its biosimilar versions of pegfilgrastim and etanercept to the US market by the fourth-quarter of 2020.

The etanercept biosimilar (YLB113), was the subject of a successful phase 3 trial in patients with rheumatoid arthritis. The study results were announced in December 2019; YLB113 was found to have clinical effects similar to those of Enbrel® but also potentially lower immunogenicity than the reference product. The company is investigating marketing partners in the US. It has partnered with Mylan in the EU and other parts of the world to market this biosimilar, which received a positive CHMP opinion in March 2020.

Nichi-Iko Pharmaceutical Company. Our February 2019 profile of Nichi-Iko revealed that it had purchased Sageant Pharmaceuticals, a maker of generics, as a gateway to the US marketplace. The company completed a phase 3 trial of NI071, an infliximab biosimilar in rheumatoid arthritis, in May 2019. Based on this completion date, we estimate that a 351(k) application for approval of NI071 can be filed before the end of Q3 2020.

Pfenex. As reported in January 2020, Pfenex originally had an interest in developing a ranibizumab (Lucentis®) biosimilar, but did not move forward with this product after phase 1/2 trials. Although seemingly turned away from the biosimilar arena, Pfenex is actively pursuing clinical development of its lead investigational product a therapeutic equivalent to teriparatide.

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