Amgen now has company as the second biosimilar competitor to Herceptin® has launched. On December 2, 2019, Mylan and Biocon announced the availability of Ogivri in the United States. A price for the new biosimilar was not announced, but it is assumed that they will need to meet or beat Amgen’s initial offering, which was … Continue reading Partners Mylan and Biocon Announce Launch of Trastuzumab Biosimilar Ogivri®
Tag: Biocon
New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers
This may be good news for partners Mylan and Biocon: Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. However, the timing for passage of these bills is questionable. The Senate’s Affordable Insulins Approval Now Act (S.2103), a bipartisan bill that was introduced by … Continue reading New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers
Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on
Biocon received a second complete response letter relating to manufacturing plant problems in Malaysia. This may seem like a straight forward issue that could hamper its efforts to produce an insulin glargine follow-on agent, but it can become a major problem barring a very quick resolution. In the filing Biocon made to the India Stock … Continue reading Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on
Pfizer Receives Approval for Trazimera, the Fourth Trastuzumab Biosimilar
A fourth trastuzumab biosimilar has been approved by the US Food and Drug Administration (FDA). Pfizer's biosimilar version of trastuzumab-qyyp (Trazimera) gained approval on March 11. The principal phase 3 study tested Trazimera against the EU-licensed version of Herceptin®. The REFLECTIONS B327-02 study found no relevant differences in the clinical and safety outcomes for patients with … Continue reading Pfizer Receives Approval for Trazimera, the Fourth Trastuzumab Biosimilar
Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount
The first pegfilgrastim biosimilar (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®. The Center for Biosimilars reported a communication from Mylan confirming the action. This is a watershed moment for the pegfilgrastim category and could signal the beginning of … Continue reading Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount
Mylan and Biocon Land First Pegfilgrastim Biosimilar Approval
The race to bring a pegfilgrastim biosimilar to market officially started on December 17, 2014. The checkered flag fluttered 3½ years later on June 4, 2018, with the Mylan/Biocon team winning on a slow track. The partners earned approval from the US Food and Drug Administration (FDA), becoming the first biosimilar to challenge for this … Continue reading Mylan and Biocon Land First Pegfilgrastim Biosimilar Approval
What Is the Biosimilar Pegfilgrastim Market Opportunity?
We’ve covered the contest to bring a biosimilar pegfilgrastim to market, with considerable depth. The progress and setbacks of Mylan/Biocon, Coherus Biosciences, Sandoz, and Apotex have been tracked. Other drug makers are also working on plans towards 351(k) applications for approval. Eventually—likely sooner than later—one or two will hit the market. Biosimilar Pegfilgrastim, Neulasta®, and … Continue reading What Is the Biosimilar Pegfilgrastim Market Opportunity?
Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
An upcoming presentation at the annual American Society of Clinical Oncology (ASCO) meeting promises equal efficacy and much improved safety for patients with early-stage breast cancer receiving Herceptin®. This change in trastuzumab dosing from a 12-month to a 6-month regimen will have ramifications for patients, health systems, and manufacturers. A number of biosimilar drug makers … Continue reading Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end. After an initial rejection, … Continue reading Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
Fujifilm Gains Further Exposure in Biosimilar Partnerships
The biosimilar industry continues to make strange bedfellows. In July 2016, I reported in the Center for Biosimilars that a subsidiary of the Japanese camera maker, Fujifilm, had jumped into the biosimilar field. The Indian pharmaceutical company Biocon announced that it has launched its new insulin glargine biosimilar in Japan. Fujifilm Pharma Co, Ltd was … Continue reading Fujifilm Gains Further Exposure in Biosimilar Partnerships