Tag: CHMP

Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate

A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.

Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not yet received approval from the European Medicines Agency (EMA), but they do have a positive opinion from the Committee on Human Medicinal Products. They expect to hear a final decision from the EMA by October and hope to market it that same month, joining the other adalimumab biosimilar drugmakers.

Those who already have approval to race include:

Manufacturer/Marketing  Partner

Molecule Designation

Brand Name
Samsung Bioepis/Merck
SB5
Imraldi
Boehringer Ingelheim
BI 695501
Cyltezo
Amgen
ABP 501
Amgevita
Sandoz
GP2017
Hyrimoz
Adapted from: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab.

Several other manufacturers are also in the running, but will be late entries. They have completed phase III studies but their biosimilar adalimumab applications are not yet filed: Coherus, Pfizer, Fresenius, and Momenta.

adalimumab biosimilarsOn October 16, Abbvie’s Humira® patent expires and the starting gate should open. We’ve not seen anything similar in the US biosimilar market. Even when Abbvie’s patents expire in 2022 and agreements go into effect, this will be more of a staggered start, with Amgen having first crack at the market in January 2023 followed by Samsung Bioepis in June of that year. That is, unless another biosimilar manufacturer refuses to sign a licensing agreement with Abbvie and launches at risk earlier.

In any case, the savings seen in the EU should be immediate and if competition is not hindered, adalimumab biosimilar prices will be slashed. It will be interesting to see how this situation plays out, with one of the world’s biologic sales leaders.

It will certainly leave American payers dreaming about what could be, but will not be, for several years at least.

Convincing Two Main Providers the Key to Pfizer’s Retacrit® Success

An unusual market situation awaits Pfizer’s new biosimilar epoetin, one that few approved medications has to face. Not only does Retacrit® need to pass muster with payers like health plans and insurers, which we assume it will, but Retacrit will need to be accepted by the two 800-pound gorillas of the kidney dialysis field as well.

epoetin use in kidney centersRetacrit and Dialysis Centers

The different part of this discussion is that providers are not usually so concentrated except in the treatment of the rarest diseases. Cancer medications are utilized by independent treatment centers throughout the country. Biosimilar agents like infliximab are also used throughout the nation by hospitals, large medical groups, and solo practices. In the case of epoetin, its primary use is in anemia related to kidney dialysis. The vast majority (85%) of kidney dialysis centers are owned by one of two networks, Fresenius Medical Care North America and DaVita Kidney Care. According to a report by Healio, Fresenius accounted for 42.6% of the total patient market in 2017, and DaVita is just behind, with 42.0% of the 453,000 patients receiving dialysis services. In other words, get buy-in from these companies and the payers, and Pfizer would have a chance to gain significant share of the epoetin market.

kidney dialysis centers
Source: https://www.healio.com/nephrology/practice-management/news/online/%7Bd894132b-b577-435e-8dec-401cd89d1b1e%7D/the-largest-dialysis-providers-in-2017-more-jump-on-integrated-care-bandwagon

Nephrologists seem to be onboard, in general. The results of national survey of nephrologists conducted in March 2018 confirm this. According to the research, only one in five respondents would be averse to switching to the biosimilar. One barrier to use may exist, however, on the provider side. The long-acting agents may be preferred by some. These include Amgen’s darbepoetin alfa (Aranesp®) and Roche’s Mircera® (methoxy polyethylene glycol-epoetin beta). To the extent that nephrologists may be less willing to use short-acting biosimilar instead of the more expensive long-acting brand may define Pfizer’s success with Retacrit. This is somewhat similar to the situation brewing with the use of injectable biosimilar pegfilgrastim (once approved and available) and the Neulasta® Onpro® delivery system. The share of use of the long-acting erythrocyte-stimulating agents has been increasing.

On May 15, 2018, Pfizer’s epoetin biosimilar Retacrit was approved by the Food and Drug Administration (FDA), the first biosimilar competitor to Epogen® and Procrit®. Retacrit is not officially available yet.

In other related biosimilar news…Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for its biosimilar version of trastuzumab.

Apotex and its Apobiologix division has claimed a significant prize—the first pegfilgrastim biosimilar approval in Western markets. None have been approved in the US or EU to date. Health Canada granted marketing authorization to the company on June 1. The new drug will be called Lapelga™.